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Laryngeal mask airway versus bag-mask ventilation or endotracheal intubation for neonatal resuscitation

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Authors

Grein AJ, Weiner GM

Background - Methods - Results - Characteristics of Included Studies - References - Data Tables & Graphs


Dates

Date edited: 22/02/2005
Date of last substantive update: 05/12/2004
Date of last minor update: / /
Date next stage expected 01/08/2006
Protocol first published: Issue 4, 2001
Review first published: Issue 2, 2005

Contact reviewer

Dr Andrew J. Grein

Department of Pediatrics, Neonatal-Perinatal Medicine
Indiana University School of Medicine, USA
699 West Drive, RR 208
James Whitcomb Riley Hospital for Children
Indianapolis
Indiana USA
46202-5119
Telephone 1: 317-274-4716
Facsimile: 317-274-2065

E-mail: ajgrein@iupui.edu

Contribution of reviewers

Grein: Developed hypotheses, literature search, study review, co-authored text, checked data entry for accuracy
Weiner: Developed hypotheses, literature search, study review, co-authored text, edited text after editorial review, entered data

Sources of Support

Internal sources of support

Indiana University School of Medicine, USA
St. Joseph Mercy Hospital, USA

External sources of support

  • None noted.

What's new

Date / Event Description

History

Date / Event Description

Synopsis

  • None noted.

Abstract

Background

Providing effective positive pressure ventilation is the single most important component of successful neonatal resuscitation. Ventilation is frequently initiated with a manual resuscitation bag and face-mask (BMV) followed by endotracheal intubation (ETT) if depression continues. These techniques may be difficult to perform successfully resulting in prolonged resuscitation or severe neonatal depression. The laryngeal mask airway (LMA) may achieve initial ventilation and successful resuscitation faster than a bag-mask device or endotracheal intubation.

Objectives

Among newborns requiring positive pressure ventilation for resuscitation, is effective ventilation and successful resuscitation achieved faster with the LMA compared with either BMV or ETT?

Search strategy

The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 3, 2004), MEDLINE (1966-November 2004), Pre-MEDLINE (November 15, 2004), CINAHL 1982-November 2004), reference lists of published trials, and Society for Pediatric Research abstracts were searched. Experts were contacted for additional references.

Selection criteria

Randomised and quasi-randomised trials

Data collection & analysis

Two reviewers independently evaluated studies, assessed methodologic quality, and extracted data using the Cochrane Neonatal Review Group criteria. Categorical treatment effects were described as relative risks and risk differences and continuous treatment effects were described as the mean difference. There were insufficient data to perform pooled analyses.

Main results

No eligible studies compared the LMA with BMV. One small randomised controlled trial comparing the LMA with ETT when BMV had been unsuccessful was included. There was no statistically significant difference between the LMA and ETT with the exception of a clinically insignificant difference in time to complete insertion of the device favouring the ETT.

Reviewers' conclusions

The LMA can achieve effective ventilation during neonatal resuscitation in a time-frame consistent with current guidelines. There is no evidence to evaluate the relative efficacy and safety of the LMA compared with BMV as the primary airway device. A single, small randomised controlled trial found no clinically significant difference between the LMA and ETT when BMV was unsuccessful. Case series and case reports suggest that the LMA can provide an effective rescue airway during resuscitation if both BMV and ETT have been unsuccessful. A well-designed randomised controlled trial comparing the LMA with BMV during neonatal resuscitation is warranted.

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Background

While most newborns are vigorous at birth, 1-13% of newborns will require assisted ventilation in the delivery room (AAP-AHA NRP Textbook; Finer 1999; Kattwinkel 1999; Niermeyer 2000; Trevisanuto 2004a; Trevisanuto 2004b; Wyckoff 2000, Zanardo 2004). Ineffective ventilatory support is the most common clinical event contributing to severe neonatal depression and the need for intensive resuscitation in the delivery room (Perlman 1995). Rapidly providing effective positive pressure ventilation is the single most important component of successful neonatal resuscitation (AAP-AHA NRP Textbook; Niermeyer 2000). During cardiopulmonary resuscitation, ventilation is frequently initiated with a manual resuscitation bag and face-mask (BMV) followed by endotracheal intubation (ETT) if neonatal depression continues. These techniques, however, may be difficult to perform successfully effective BMV is a skill that must be learned and practiced. Incorrect mask placement allows air to leak around the mask while excessive pressure on the mask may result in soft tissue damage to facial structures. Laboratory investigations have suggested that commonly used BMV devices may deliver inconsistent tidal volumes, excessive peak pressures, and inadequate positive end-expiratory pressure (Milner 1984; Finer 2001). Videotape recordings of actual neonatal resuscitations demonstrated that resuscitators frequently were unable to achieve adequate chest expansion using a bag-mask device (Carbine 2000). Endotracheal intubation is attempted when adequate ventilation cannot be established, meconium must be suctioned from the airway, intra-tracheal epinephrine must be administered, or when resuscitation is prolonged. This procedure requires considerable training, experience, and skill. Physicians completing pediatric training frequently fail to intubate the trachea despite multiple attempts (Falck 2003). Even experienced resuscitators may require prolonged attempts to successfully intubate the neonatal trachea (Noblett 1995, Carbine 2000). Furthermore, bag-mask ventilation and endotracheal intubation may not be possible among infants with airway obstructions and cranio-facial anomalies such as the Pierre-Robin sequence. In these infants, additional airway adjuncts and advanced procedures may be required. The laryngeal mask airway (LMA) is an airway device that may provide an alternative to either BMV or ETT for newborns requiring assisted ventilation in the delivery room (Trevisanuto 2004c).

The LMA is a small mask with an inflatable cuff attached to a silicone rubber airway tube. It is inserted orally using the operator's index finger and guided along the hard palate without laryngoscopy or other instruments. When the device is fully inserted, the mask lumen sits over the laryngeal opening while the cuff conforms to the contours of the hypopharynx occluding the esophagus with a low-pressure seal. After inflating the cuff, the LMA can be used to control the airway of spontaneously breathing patients or to provide positive pressure ventilation. Since its introduction, the LMA has been used for both adult and pediatric anaesthesia and is the initial adjunctive airway device recommended by the American Society of Anaesthesiologists' difficult airway algorithm (Benumof 1996). The potential advantages of using a LMA for neonatal resuscitation include the ease of insertion without laryngoscopy and minimal instrumentation of the larynx. Potential disadvantages include gastric distention, inadequate alveolar ventilation, and possible difficulty suctioning the airway or administering emergency intra-tracheal medications.

The most recent statements from the Pediatric Working Group of the International Liaison Committee on Resuscitation (ILCOR), the American Academy of Pediatrics Neonatal Resuscitation Program Steering Committee, and the American Heart Association Emergency Cardiovascular Care Pediatric Resuscitation Subcommittee of the Emergency have recommended considering the LMA for airway control when both BMV and ETT have been unsuccessful (Kattwinkel 1999; Niermeyer 2000). These organizations did not recommend routinely using the LMA instead of either (i) BMV as the primary airway device or (ii) ETT as the secondary device because of insufficient evidence documenting safety and efficacy at the time of their review. Given that establishing ventilation is the most critical aspect of successful neonatal resuscitation, it is important to answer each of the following two questions: (1) Does the LMA achieve initial ventilation and successful resuscitation faster than a bag-mask device, and (2) When bag-mask ventilation is either insufficient or ineffective, does the LMA achieve effective ventilation and successful resuscitation faster than endotracheal intubation.

Objectives

Primary objectives: (1) Among all newborns requiring positive pressure ventilation for cardio-pulmonary resuscitation, is effective positive pressure ventilation and successful resuscitation achieved faster with the laryngeal mask airway compared with bag-mask ventilation? (2) When bag-mask ventilation is either insufficient or ineffective, is effective positive pressure ventilation and successful resuscitation achieved faster with the laryngeal mask airway compared with endotracheal intubation?

Planned Subgroup analyses:

Population: Low birth weight (< 2500 grams), very low birth weight (< 1500 grams), newborns with craniofacial anomalies, non-delivery room resuscitations

Intervention: Resuscitator (nurse, respiratory therapist, physician, trainee)

Criteria for considering studies for this review

Types of studies

Randomised and quasi-randomised controlled studies were included. Studies describing LMA placement in the operating room for airway control during anaesthesia and those describing the LMA for airway control during diagnostic bronchoscopy were excluded.

Types of participants

  1. Term or preterm infants who required positive pressure ventilation for cardiopulmonary resuscitation due to any cause during the first 28 days of life.
  2. Term or preterm infants who required positive pressure ventilation for cardiopulmonary resuscitation due to any cause during the first 28 days of life, where bag-mask ventilation was found to be either insufficient or ineffective.

Types of interventions

  1. LMA used for initiating positive pressure ventilation, with any insertion technique, for neonatal cardiopulmonary resuscitation compared with bag-mask ventilation.
  2. LMA used as a secondary airway device, with any insertion technique, for neonatal cardiopulmonary resuscitation, when bag-mask ventilation was found to be insufficient or ineffective, compared with endotracheal intubation.

Types of outcome measures

Primary outcome measures:
  1. Time (seconds) from birth, or from beginning of intervention, until heart rate greater than 100 beats/minute.
  2. Time (seconds) from birth, or from beginning of intervention, required to correctly insert the device
  3. Number of attempts to complete procedure.
    • After the initial review of the potentially eligible studies, this outcome measure was changed to the categorical outcome "Failure to correctly insert the device after one attempt
  4. Duration (seconds) of resuscitation
  5. Death in the delivery room
  6. Death, all causes, prior to hospital discharge
Secondary outcome measures:
  1. Time (seconds) from birth, or from beginning of intervention, to achieve effective chest expansion
  2. Time (seconds) from birth, or from beginning of intervention, to pink skin color
  3. Number of times endotracheal intubation required (LMA vs. BMV studies only)
  4. Objective ratings (any scale) of operator satisfaction
  5. Apgar score < 7 at five minutes (delivery room resuscitation studies only). This outcome measure was added after the initial review of potentially eligible studies.
  6. Frequency of procedure failures
  7. Frequency of pneumothorax
  8. Frequency of epinephrine administration
  9. Frequency of device malposition and/or dislodgement
  10. Frequency of post-resuscitation oral, airway, or facial trauma; stridor; suspected aspiration; or vocal cord paralysis
  11. Frequency of device failure (e.g. cuff leak, tube crack)

Search strategy for identification of studies

The standard search method of the Cochrane Neonatal Review Group (CNRG) described in the Cochrane Library and CNRG Guidelines was used.

  1. Published articles: Eligible trials were identified from MEDLINE (OVID and PubMed, 1966 - November, 2004), Pre-MEDLINE (November 15, 2004), CINAHL (1982 - November, 2004), and the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 3, 2004). We used the following search strategy: (exp Laryngeal Mask (MeSH) or laryngeal mask$.mp) or LMA.tw., limited (MEDLINE, Pre-MEDLINE, and CINAHL) to all infant (birth to 1 year). Pre-MEDLINE and CENTRAL were also searched using the terms (exp Laryngeal Masks (MeSH) or laryngeal mask$.mp or LMA.tw. and exp Resuscitation (MeSH). The search was not limited by either language or publication type in order to maximize search sensitivity. The bibliographies of retrieved articles were reviewed for additional references. Two members [Dr. Udaeta (Mexico) and Dr. Carlo (USA)] of the Neonatal Task force of the International Liaison Committee on Resuscitation were contacted to identify additional references. Esmail 2002 was not identified using our electronic or hand-search strategy but was brought to our attention by Dr. Udaeta. We were able to locate the full-text of this study on-line (www.google.com, last accessed July 7, 2004)) with the search terms "LMA and neonate".
  2. Published abstracts: Abstracts of the Society for Pediatric Research (USA) published in Pediatric Research (1993 - 2004) were hand-searched using the key words: laryngeal mask and resuscitation.
  3. Unpublished trials: After completing the initial review of retrieved articles, we attempted to contact authors that commented on pending trials, authors of included studies, and three authors of case series that did not meet inclusion criteria (Brimacombe, J; Paterson, S; Trevisunato, D) to identify unpublished or pending trials. We successfully contacted Drs. Brimacombe and Trevisunato; no unpublished or pending trials were identified.

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Methods of the review

The standard methods of the Cochrane Collaboration and the Neonatal Review Group were used as described in the Cochrane Collaboration Handbook. Two reviewers independently evaluated and scored potentially relevant studies for inclusion and methodologic quality. The assessment of methodologic quality was based on a review of the opportunity for bias in accordance with the standard methods of the Neonatal Review Group. Studies were scored for blinding of randomisation, blinding of the intervention, completeness of follow-up, and blinding of outcome measurements. Two investigators independently extracted and coded all data from included trials using a standardized form. To the extent possible, outcome data were extracted on all randomised patients. We attempted, unsuccessfully, to contact one investigator (Esmail 2002) for additional outcome measurements and clarification regarding the methods of randomisation and blinding. Data were entered into RevMan by a single investigator and checked for accuracy by a second investigator. There were no disagreements regarding the assessment of trials for inclusion, assessment of methodologic quality, or data extraction.

Data were analysed using the standard statistical methods of the Cochrane Neonatal Review Group. Categorical treatment effects are described as relative risks, risk differences, and the number needed to treat with 95% confidence intervals. Continuous treatment effects are described as the mean difference with 95% confidence intervals. There were insufficient data to performed pooled analyses. A fixed effect model was assumed and we would have used the heterogeneity (I2)statistic to help decide on pooling.

Description of studies

Five potentially eligible studies were identified. One study (Esmail 2002) met the inclusion criteria. Esmail 2002 compared the size-1 LMA vs. ETT among newborns at a single center (Cairo University, Egypt, 1999-2000) requiring resuscitation in the delivery room. In each treatment group, the enrolled subjects were similar with respect to birth weight and gestational age. The mean birthweight (SD) was 3369 (655) grams in the LMA group and 3450 (565) grams in the ETT group. The authors do not describe how or when randomisation was performed. It is unclear how many potentially eligible subjects were excluded or if any randomised subjects were excluded after randomisation. The number of placement attempts made with each device, elapsed time, skin color, heart rate, spontaneous respiratory rate, and Apgar score (1, 5, 10 minutes) were recorded. The individual completing this assessment was not blinded to treatment allocation. The authors did not provide details describing who made these outcome assessments. A fibreoptic laryngoscope was used to ascertain the position of the LMA and to evaluate for soft tissue trauma. In the ETT group, it is not clear how the position of the ETT and soft tissue trauma were assessed. It is not clear when these placement and trauma assessments were made. The resuscitators' level of training and professional credentials were not described.

Four non-randomised, single-center, observational studies were excluded from this review (Paterson 1994; Gandini 1999; Trevisanuto 2004a; Zanardo 2004). Two of the excluded studies (Paterson 1994; Gandini 1999) were prospective case-series describing delivery room resuscitation using a LMA without a comparison group. One study (Trevisanuto 2004a) was a retrospectively assembled LMA case-series compared with both a historical and a concurrent group of newborns resuscitated using a bag-mask device. The allocation to LMA or BMV was at the resuscitator's discretion without randomisation. The fourth study (Zanardo 2004) was a retrospectively assembled cohort study designed to assess the rate of neonatal depression after elective cesarean section delivery compared with vaginal delivery. The authors included a sub-analysis in which resuscitations using the LMA were compared to those using an ETT following either cesarean section or vaginal delivery. In this study, the decision to use a LMA or ETT was left to the resuscitator's discretion without randomisation. It appears that some of the newborns reported in Trevisanuto 2004a are reported again in Zanardo 2004.

Fifteen case reports describing 15 neonates resuscitated using the LMA were excluded from this review because they were not randomised trials (Baker 2004; Baraka 1995; Brimacombe 1995a; Brimacombe 1999; Brimacombe 2004; Bucx 2003; Denny 1990; Fernandez-Jur 2002; Fraser 1999; Fraser 1999b; Gandini 2003; Mawer 1995; Nagahama 1995; Trawoger 1999; Yao 2004). Several of these reports described newborns with cranio-facial anomalies that required resuscitation and could not be ventilated with BMV or intubated with an ETT. In these cases, the LMA provided a rescue airway. A survey of current practice in a single region of Italy was excluded because it was not a randomised trial (Trevisanuto 2004b). This survey described 101 newborns resuscitated in the delivery room using a LMA. These subjects were included in two other reports by the same authors (Trevisanuto 2004a; Zanardo 2004).

Methodological quality of included studies

In the study by Esmail 2002, the methods, timing, and concealment of randomisation were not stated. The intervention was not blinded. Outcome data were provided for all 40 of the described subjects, however, it is unclear if there were any randomised subjects that were excluded post-randomisation because of the need for chest compressions or the identification of a congential anomaly. In addition, the duration of follow-up was not clear. The individual(s) measuring outcomes during the intervention (number of attempts, Apgars, heart rate) did not appear to be masked to treatment allocation. The individual(s) performing fibreoptic assessments of LMA position and soft-tissue trauma were not masked to treatment allocation.

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Results

No eligible studies were identified comparing the LMA with BMV. One study (Esmail 2002) comparing the LMA to ETT during neonatal resuscitation contributed data for this review.

Laryngeal Mask Airway (LMA) vs. Bag-mask ventilation (BMV)

No eligible studies identified.

Laryngeal Mask Airway (LMA) vs. Endotracheal Intubation (ETT)

Primary Outcomes:

  1. Time (seconds) until heart rate greater than 100 beats/minute: Esmail 2002 graphically reported the average heart rate ± SD for both groups at 10 second intervals (0-90 seconds). The average heart rate improved over the first 90 seconds in both groups and the authors stated that there was no statistically significant difference between the groups at any point.
  2. Time (seconds) required to correctly insert the device: There was a statistically significant increase in the time required to correctly insert the LMA compared with the ETT [mean difference 2.50 seconds (1.27-3.73)]. This is not likely to be a clinically important difference. No subject required cross-over to the alternate device. Overall, the time required to insert both devices [mean (SD) seconds] was very short [LMA 10 (2.5), ETT 7.5 (1.3)].
  3. Failure to correctly insert the device after one attempt: There was no statistically significant difference in the LMA group compared with the ETT group [RR 1.50 (0.28, 8.04), RD 0.05 (-0.15-0.25)]. The resuscitators had a very high first time success rate with both devices (LMA 17/20, ETT 18/20). No subject required cross-over to the alternate device.
  4. Duration (seconds) of resuscitation: Not reported
  5. Death in the delivery room: There were no delivery room deaths in either group.
  6. Death, all causes, before hospital discharge: No deaths were reported, however, the duration of follow-up is not reported.

Secondary Outcomes:

  1. Time (seconds) to achieve effective chest expansion: Not reported
  2. Time (seconds) to pink skin color: Esmail 2002 graphically reported the number of subjects with uniform pink and uniform cyanotic skin color at 10 second intervals (0-90 seconds). The skin color improved over the first 90 seconds in both groups and the authors stated that there was no statistically significant difference between the groups at any point.
  3. Number of times endotracheal intubation required (LMA vs. BMV studies only): Not applicable.
  4. Objective ratings (any scale) of operator satisfaction: Not reported
  5. Apgar score < 7 at 5 minutes: None reported in either group.
  6. Frequency of procedure failures: None reported in either group.
  7. Frequency of pneumothorax: None reported in either group.
  8. Frequency of epinephrine administration: No subject received epinephrine in either group.
  9. Frequency of device malposition and/or dislodgement: Not reported
  10. Frequency of post-resuscitation oral, airway, or facial trauma; stridor; suspected aspiration; or vocal cord paralysis: There was no statistically significant difference in soft tissue trauma (epiglottis, uvula, tongue) between the LMA and the ETT treated groups [RR 2.00 (0.58, 6.91), RD 0.15 (-0.10, 0.40)]. It is unclear when this outcome was ascertained.
  11. Frequency of device failure (e.g. cuff leak, tube crack): None reported in either group.

Discussion

Establishing effective positive pressure ventilation is the single most important aspect of successful neonatal resuscitation (AAP-AHA NRP Textbook). It is, therefore, critically important to identify the most effective device for delivering positive pressure ventilation. Bag-mask ventilation and endotracheal intubation are the most common traditional treatment options, but both have limitations including difficulty achieving effective and consistent tidal volumes, difficulty making an effective seal, a requirement for extensive training and practice, and difficulty using either device among newborns with cranio-facial anomalies. This review sought to establish whether the laryngeal mask airway would be an effective alternative to either bag-mask ventilation or endotracheal intubation. We found limited evidence to evaluate either of these questions. We identified no randomised trials evaluating the LMA compared with BMV for neonatal resuscitation and only one randomised trial (Esmail 2002) comparing the laryngeal mask airway with endotracheal intubation.

Methodologic problems limit both the validity and applicability of the only study included in this review. Esmail 2002 was subject to bias in enrollment, allocation, and outcome measurement. The authors did not provide important details about the recruitment or randomisation process. Although the study enrolled newborns who had failed to respond to bag-mask ventilation, none of the subjects were severely depressed and they may not have been representative of the population of neonates requiring prolonged resuscitation in the delivery room. Infants requiring chest compressions were excluded from enrollment. If the LMA achieves effective ventilation quickly, it may decrease the number of newborns that ultimately require chest compressions (Perlman 1995). It will be important, however, to establish whether the LMA can be used during chest compressions before recommending this device as either the primary airway or the first-choice secondary airway. Although the investigators found a statistically shorter time for ETT placement compared with LMA placement, this finding may not be generalizable to other settings. All of the resuscitators in this study appeared to have been anaesthesiologists. They had substantially higher rates of success and completed ETT in shorter times than those reported for pediatrician-directed resuscitations. Carbine 2000 found that neonatal resuscitation teams consisting of either a staff neonatologist, neonatal fellow, neonatal nurse practitioner, or senior pediatric resident successfully placed an ETT during the first attempt in only 7/12 newborns and only 4/12 were intubated in < 20 seconds. Similarly, Falck 2003 reported that only 50-62% of neonatal intubation procedures were successful on the first or second attempt by pediatric residents. A total of 35% of neonates were never successfully intubated by a pediatric resident after a maximum of 4 attempts. The higher than expected rate of success for the control (ETT) treatment may have limited the investigators' ability to identify a difference between groups. Finally, it is unclear if the investigators assessing outcomes were blinded to treatment allocation, when certain outcomes (LMA position, trauma) were actually ascertained, and how long subjects were followed. Overall, Esmail 2002 found no clinically significant difference between the LMA and ETT, among skilled operators, if attempts with a bag-mask device were unsuccessful. This study did not address the use of the LMA as an alternative to BMV for initial ventilation; however, all of the infants in the LMA group were successfully resuscitated using the LMA and had previously failed to respond to BMV.

We were unable to identify any randomised trials directly comparing the LMA with BMV for initial positive pressure ventilation. At the present time, the best available evidence evaluating the safety and efficacy of the LMA for initial ventilation comes from three non-randomised observational studies. Paterson 1994, Gandini 1999, and Trevisanuto 2004a reported case series including a total of 220 newborns treated at three centers. Paterson 1994 reported the first prospective series using the LMA in place of BMV in the delivery room for term and near-term newborns. The study team resuscitated 21 newborns (weight range 2235-4460 grams) and successfully inserted the LMA during the first attempt in all 21 newborns. The heart rate exceeded 100 bpm within 30 seconds in 20/21 patients. One newborn failed to respond to both LMA insertion and subsequent endotracheal intubation. The time [mean ± SD, (range)] required for LMA placement in the remaining 20 subjects was 8.6 ± 1.4 seconds (7-12). Gandini 1999 subsequently reported the largest delivery room series. In contrast to Paterson 1994 and Esmail 2002, Gandini 1999 included newborns without specified weight or gestational age limits. The subjects included 29 "low birth weight" newborns with six newborns < 1500 grams. The smallest subject was 1000 grams. The LMA was inserted successfully during the first attempt in all 104 newborns and effective ventilation was achieved in 103/104. Adequate chest expansion was achieved by 10 seconds (mean) in both normal and low birth-weight newborns. One subject, without apparent meconium staining, did not improve with either the LMA or an ETT and was found to have severe meconium aspiration at postmortem examination. Finally, Trevisanuto 2004a retrospectively compared all neonatal resuscitations at a single center during two different years. The LMA was not used at all in 1996, but was used at the physician's discretion during 25% of near-term (> 34 weeks, > 2000 grams) deliveries in 2000. Trevisanuto 2004A then compared all newborns resuscitated with the LMA in 2000 with a gestational age matched group resuscitated in the same year with BMV. The LMA was "easily inserted" and provided "effective ventilation" in 94/95 neonates during resuscitation. The infant that did not respond was ultimately intubated with an ETT and was found to have a tension pneumothorax. In the gestational age matched BMV comparison group, there were four newborns that did not respond to BMV and were successfully treated with the LMA. Two of these newborns had micrognathia. In ten additional case reports, the LMA was used as a life-saving rescue airway for neonates when both BMV and ETT were unsuccessful (Baker 2004; Baraka 1995; Brimacombe 1995a; Brimacombe 1999; Brimacombe 2004; Bucx 2003; Denny 1990; Fraser 1999; Gandini 2003; Mawer 1995; Trawoger 1999).

Reviewers' conclusions

Implications for practice

There is no evidence from controlled trials to evaluate the relative efficacy and safety of the laryngeal mask airway (LMA) compared with bag-valve-mask ventilation (BMV) as the primary airway device during neonatal resuscitation. A single, small randomised controlled trial found no clinically significant difference between the LMA and ETT as a secondary airway device when BMV was unsuccessful. Methodologic problems with this single study, however, limit both the interpretation and applicability of the results. There is insufficient evidence to evaluate the LMA in the setting of meconium-stained amniotic fluid, chest compressions, or for the delivery of emergency intra-tracheal medications.

The best available evidence comes from observational studies, and suggests that the LMA can provide a rescue airway and achieve effective positive pressure ventilation during resuscitation of the newborn infant if both BMV and ETT have been unsuccessful. Although the evidence supporting this conclusion is largely extrapolative and based on case reports, the non-invasive nature of LMA placement in comparison with the alternative (tracheostomy), and the practical difficulties of designing a randomised controlled trial in this unpredictable emergency situation make it unlikely that definitive evidence will become available.

Implications for research

Randomised controlled trials comparing the LMA with BMV as the primary airway device during neonatal resuscitation are warranted. Additional randomised controlled trials are warranted comparing the LMA with ETT during neonatal resuscitation when BMV has been unsuccessful. These trials should include both term and preterm newborns requiring positive pressure ventilation, chest compressions, and emergency intratracheal medications. Trials comparing neonatal "manikin only" training with "live-patient" training are indicated to further evaluate the training requirements for neonatal resuscitators.

Acknowledgements

The authors would like to acknowledge Dr. Enrique Udaeta (Mexico) and Dr. Waldemar Carlo (USA) from the International Liaison Committee on Resuscitation for their assistance in identifying additional references.

Potential conflict of interest

  • None noted.

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Characteristics of studies

Characteristics of Included Studies

Study Methods Participants Interventions Outcomes Notes Allocation concealment
Esmail 2002 Blinding of randomization: Can't tell, the randomization method is not described. Blinding of intervention: No. Complete follow-up: Yes, for the 40 described subjects, but it is unclear if there were any post-randomisation exclusions and the duration of follow-up is not described. Blinding of outcome measurement: Can't tell, not described. The laryngoscopic assessment of LMA position could not have been blinded. Single center study (Cairo University Hospital, Egypt, 1999-2000). Newborns with expected gestation greater than/or equal to 35 weeks and expected weight greater than/or equal to 2.5 kg following Cesarean section delivery with Apgar 0-3 after one minute of positive pressure ventilation using a bag-mask device. Newborns with congenital anomalies and those requiring chest compressions were excluded. Unknown how many potentially eligible subjects were not enrolled. Size-1 LMA (n=20) or ETT (n=20). For LMA, positive pressure ventilation using a Jackson-Rees modification of an Ayres T-piece circuit with a pressure manometer to a maximum of 20 cm H2O pressure. Allowed 3 LMA attempts, then cross-over to ETT. For ETT, two attempts within 40 seconds were allowed, then cross-over to LMA. Time required to place device; time of positive pressure ventilation; skin color, heart rate, spontaneous respiratory effort, breath sounds (measured at 10 second intervals starting a beginning of insertion attempt); Apgar score at 1, 5, 10 minutes; pulse oximetry (measured every minute until resuscitation completed); "response to resuscitation and airway patency" (15-30 second intervals); LMA position and soft tissue trauma (epiglottis, tongue, uvula) using a fiberoptic laryngoscope (not stated when this assessment took place). B

Characteristics of excluded studies

Study Reason for exclusion
Baker 2004 Not a randomized or quasi-randomized trial. A single patient case report.
Baraka 1995 Not a randomized or quasi-randomized trial. A single patient case report.
Brimacombe 1995a Not a randomized or quasi-randomized trial. A single patient case report.
Brimacombe 1999 Not a randomized or quasi-randomized trial. A single patient case report.
Brimacombe 2004 Not a randomized or quasi-randomized trial. A case report describing 2 newborns, 1 requiring resuscitation.
Bucx 2003 Not a randomized or quasi-randomized trial. A single patient case report.
Denny 1990 Not a randomized or quasi-randomized trial. A single patient case report.
Fernandez-Jur 2002 Not a randomized or quasi-randomized trial. A single patient case report.
Fraser 1999 Not a randomized or quasi-randomized trial. A case report describing 2 neonates requiring resuscitation.
Fraser 1999b Not a randomized or quasi-randomized trial. Additional information about one patient described in Fraser 1999.
Gandini 1999 Not a randomized or quasi-randomized trial. Prospective case-series without a comparison group.
Gandini 2003 Not a randomized or quasi-randomized trial. A single patient case report.
Mawer 1995 Not a randomized or quasi-randomized trial. A single patient case report.
Nagahama 1995 Not a randomized or quasi-randomized trial. A single patient case report.
Paterson 1994 Not a randomized or quasi-randomized trial. Prospective case-series without a comparison group.
Trawoger 1999 Not a randomized or quasi-randomized trial. A single patient case report.
Trevisanuto 2004a Not a randomized or quasi-randomized trial. Retrospective case-series with historical and concurrent, non-randomized comparison groups.
Trevisanuto 2004b Not a randomized or quasi-randomized trial. A survey of anesthesiologists and pediatricians.
Yao 2004 Not a randomized or quasi-randomized trial. A single patient case report.
Zanardo 2004 Not a randomized or quasi-randomized trial. Retrospective cohort study with a non-randomized comparison group.

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References to studies

Included studies

Esmail 2002

{published data only}

Esmail N, Saleh M, Ali A. Laryngeal mask airway versus endotracheal intubation for Apgar score improvement in neonatal resuscitation. Egyptian Journal of Anesthesiology 2002;18:115-21.

Excluded studies

Baker 2004

{published data only}

Baker PA, Aftimos S, Anderson BJ. Airway management during an EXIT procedure for a fetus with dysgnathia complex. Paediatric Anaesthesia 2004;14:781-6.

Baraka 1995

{published data only}

Baraka A. Laryngeal mask airway for resuscitation of a newborn with Pierre-Robin syndrome. Anesthesiology 1995;83:645-6.

Brimacombe 1995a

{published data only}

Brimacombe JR, De Maio B. Emergency use of the laryngeal mask airway during helicopter transfer of a neonate.[see comment]. Journal of Clinical Anesthesia 1995;7:689-90.

Brimacombe 1999

{published data only}

Brimacombe J, Gandini D. Airway rescue and drug delivery in an 800 g neonate with the laryngeal mask airway. Paediatric Anaesthesia 1999;9:178.

Brimacombe 2004

{published data only}

Brimacombe J, Gandini D, Keller C. The laryngeal mask airway for administration of surfactant in two neonates with respiratory distress syndrome. Paediatric Anaesthesia 2004;14:188-90.

Bucx 2003

{published data only}

Bucx MJ, Grolman W, Kruisinga FH, Lindeboom JA, Van Kempen AA. The prolonged use of the laryngeal mask airway in a neonate with airway obstruction and Treacher Collins syndrome. Paediatric Anaesthesia 2003;13:530-3.

Denny 1990

{published data only}

Denny NM, Desilva KD, Webber PA. Laryngeal mask airway for emergency tracheostomy in a neonate. Anaesthesia 1990;45:895.

Fernandez-Jur 2002

{published data only}

Fernandez-Jurado MI, Fernandez-Baena M. Use of laryngeal mask airway for prolonged ventilatory support in a preterm newborn. Paediatric Anaesthesia 2002;12:369-70.

Fraser 1999

{published data only}

Fraser J, Hill C, McDonald D, Jones C, Petros A. The use of the laryngeal mask airway for inter-hospital transport of infants with type 3 laryngotracheo-oesophageal clefts. Intensive Care Medicine 1999;25:714-6.

Fraser 1999b

{published data only}

Fraser J, Petros A. High-frequency oscillation via a laryngeal mask airway. Anaesthesia 1999;54:404.

Gandini 1999

{published data only}

Gandini D, Brimacombe JR. Neonatal resuscitation with the laryngeal mask airway in normal and low birth weight infants. Anesthesia and Analgesia 1999;89:642-3.

Gandini 2003

{published data only}

Gandini D, Brimacombe J. Laryngeal mask airway for ventilatory support over a 4-day period in a neonate with Pierre Robin sequence. Paediatric Anaesthesia 2003;13:181-2.

Mawer 1995

{published data only}

Mawer RJ. Equipment for paediatric resuscitation.[see comment]. Anaesthesia 1995;50:87-8.

Nagahama 1995

{published data only}

Nagahama H, Suzuki Y, Tateda T, Aoki T, Takahashi K, Shimoyama T. [The use of a laryngeal mask in a newborn infant with Nager acrofacial dysostosis]. Masui - Japanese Journal of Anesthesiology 1995;44:1555-8.

Paterson 1994

{published data only}

Paterson SJ, Byrne PJ, Molesky MG, Seal RF, Finucane BT. Neonatal resuscitation using the laryngeal mask airway.[see comment]. Anesthesiology 1994;80:1248-53.

Trawoger 1999

{published data only}

Trawoger R, Mann C, Mortl, Riha K. Use of laryngeal masks in the resuscitation of a neonate with difficult airway. Arch Dis Child Fetal Neonatal Ed 1999;81:F160.

Trevisanuto 2004a

{published data only}

Trevisanuto D, Micaglio M, Pitton M, Magarotto M, Piva D, Zanardo V. Laryngeal mask airway: is the management of neonates requiring positive pressure ventilation at birth changing? Resuscitation 2004;62:151-7.

Trevisanuto 2004b

{published data only}

Trevisanuto D, Ferrarese P, Zanardo V, Chiandetti L. Laryngeal mask airway in neonatal resuscitation: a survey of current practice and perceived role by anaesthesiologists and paediatricians. Resuscitation 2004;60:291-6.

Yao 2004

{published data only}

Yao C, Wang J, Tai Y, Tsai T, Wu J. Successful management of a neonate with Pierre-Robin syndrome and severe upper airway obstruction by long term placement of a laryngeal mask airway. Resuscitation 2004;61:97-99.

Zanardo 2004

{published data only}

Zanardo V, Simbi AK, Savio V, Micaglio M, Trevisanuto D. Neonatal resuscitation by laryngeal mask airway after elective cesarean section. Fetal Diagnosis and Therapy 2004;19:228-31.

* indicates the primary reference for the study

Other references

Additional references

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Auden SM, Lerner GM. Blind intubation via the laryngeal mask: a word of caution.[comment]. Paediatric Anaesthesia 2000;10:452.

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Benumof J. Laryngeal mask airway and the ASA difficult airway algorithm. Anesthesiology 1996;84:686-99.

Brain 1983

Brain AI. The laryngeal mask - a new concept in airway management. British Journal of Anaesthesia 1983;55:801-5.

Brimacombe 1995b

Brimacombe J, Gandini D. Resuscitation of neonates with the laryngeal mask airway--a caution. Pediatrics 1995;95:453-4.

Carbine 2000

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Ellis DS, Potluri PK, O'Flaherty JE, Baum VC. Difficult airway management in the neonate: a simple method of intubating through a laryngeal mask airway. Paediatric Anaesthesia 1999;9:460-2.

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Finer NN, Horbar JD, Carpenter JH. Cardiopulmonary resuscitation in the very low birthweight infant: the Vermont Oxford Network experience. Pediatrics 1999;104:428-34.

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Gandini D, Brimacombe J. Manikin training for neonatal resuscitation with the laryngeal mask airway. Pediatric Anesthesia 2004;14:493-4.

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Hansen TG, Joensen H, Henneberg SW, Hole P. Laryngeal mask airway guided tracheal intubation in a neonate with the Pierre Robin syndrome. Acta Anaesthesiologica Scandinavica 1995;39:129-31.

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Osses H, Poblete M, Asenjo F. Laryngeal mask for difficult intubation in children.[see comment]. Paediatric Anaesthesia 1999;9:399-401.

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Park C, Bahk JH, Ahn WS, Do SH, Lee KH. The laryngeal mask airway in infants and children. Canandian Journal of Anaesthesia 2001;48:413-7.

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Pennant 1992

Pennant JH, Walker MB. Comparison of the endotracheal tube and laryngeal mask in airway management by paramedical personnel. Anesthesia and Analgesia 1992;74:531-4.

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Prengel 2001

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Roberts I, Allsop P, Dickinson M, Curry P, Eastwick-Field P, Eyre G. Airway management training using the laryngeal mask airway: a comparison of two different training programmes. Resuscitation 1997;33:211-4.

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Rowbottom SJ, Simpson DL, Grubb D. The laryngeal mask airway in children. A fibreoptic assessment of positioning. Anaesthesia 1991;46:489-91.

Sacks 2000

Sacks M, Marsh D. Bilateral recurrent laryngeal nerve neuropraxia following laryngeal mask insertion: a rare cause of serious upper airway morbidity. Paediatric Anaesthesia 2000;10:435-7.

Stillman 2003

Stillman PC. Lingual oedema associated with the prolonged use of an inappropriately large laryngeal mask airway (LMATM) in an infant. Paediatric Anaesthesia 2003;13:637-9.

Stocks 2002

Stocks RM, Egerman R, Thompson JW, Peery M. Airway management of the severely retrognathic child: use of the laryngeal mask airway. Ear, Nose, & Throat Journal 2002;81:223-6.

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Stone BJ. The use of the laryngeal mask airway by nurses during cardiopulmonary resuscitation. Results of a multicentre trial. Anaesthesia 1994;49:3-7.

Theroux 1995

Theroux MC, Kettrick RG, Khine HH. Laryngeal mask airway and fiberoptic endoscopy in an infant with Schwartz-Jampel syndrome. Anesthesiology 1995;82:605.

Trevisanuto 2004

Trevisanuto D, Ferrarese P, Zanardo V, Chiandetti L. Laryngeal mask airway in neonatal resuscitation: a survey of current practice and perceived role by anaesthesiologists and paediatricians. Resuscitation 2004;60:291-6.

Trevisanuto 2004c

Trevisanuto D, Micaglio M, Ferrarese P, Zanardo V. The laryngeal mask airway: potential applications in neonates. Archives of Disease in Childhood Fetal & Neonatal Edition 2004;89:F485-9.

Trevisanuto 2004d

Trevisanuto D, Grazzina N, Micaglio M, Ferrarese P, Zanardo V. Laryngeal mask airway as a delivery channel for administration of surfactant in preterm infants with RDS. Pediatric Research 2004;55:515A.

Webster 1995

Webster AC, Reid WD, Siebert LF, Taylor MD. Laryngeal mask airway for anaesthesia for cryopexy in low birth weight infants. Canadian Journal of Anaesthesia 1995;42:361-2.

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Wyckoff M, Perlman J. Cardiopulmonary resuscitation in very low birth weight infants. Pediatrics 2000;106:618-20.

[top]

Data and analyses

01 Laryngeal mask airway versus endotracheal intubation

Comparison or outcome Studies Participants Statistical method Effect size
01.01 Time to complete procedure (seconds) 1 40 WMD (fixed), 95% CI 2.50 [1.27, 3.73]
01.02 Failure to correctly insert the device after one attempt 1 40 RR (fixed), 95% CI 1.50 [0.28, 8.04]
01.03 Soft tissue trauma after device inserted 1 40 RR (fixed), 95% CI 2.00 [0.58, 6.91]

Notes

  • None noted.

Additional tables

  • None noted.

Contact details for co-reviewers

Dr Gary M. Weiner

Pediatrics, Neonatal-Perinatal Medicine
St. Joseph Mercy Hospital
5301 East Huron River Drive
Ann Arbor
Michigan USA
48106
Telephone 1: 734-712-3325
Facsimile: 734-712-5525

E-mail: weinerg@trinity-health.org


The review is published as a Cochrane review in The Cochrane Library, Issue 2, 2005 (see http://www.thecochranelibrary.com External Web Site Policy for information). Cochrane reviews are regularly updated as new evidence emerges and in response to comments and criticisms, and The Cochrane Library should be consulted for the most recent recent version of the review.