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Respiratory function monitoring to reduce mortality and morbidity in newborn infants receiving resuscitation

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Authors

Georg M Schmölzer1, Colin J Morley2, Peter G Davis1

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


1Department of Newborn Research, The Royal Women's Hospital, Parkville, Australia [top]
2Royal Women's Hospital (Melbourne), Great Shelford, UK [top]

Citation example: Schmölzer GM, Morley CJ, Davis PG. Respiratory function monitoring to reduce mortality and morbidity in newborn infants receiving resuscitation. Cochrane Database of Systematic Reviews 2010, Issue 9. Art. No.: CD008437. DOI: 10.1002/14651858.CD008437.pub2.

Contact person

Georg M Schmölzer

Department of Newborn Research
The Royal Women's Hospital
20 Flemington Road
Parkville
Victoria
3052
Australia

E-mail: georg.schmoelzer@me.com

Dates

Assessed as Up-to-date: 29 June 2010
Date of Search: 31 March 2010
Next Stage Expected: 29 June 2012
Protocol First Published: Issue 3, 2010
Review First Published: Issue 9, 2010
Last Citation Issue: Issue 9, 2010

What's new

Date / Event Description

History

Date / Event Description

Abstract

Background

A respiratory function monitor is routinely used in neonatal intensive care units to continuously measure and display airway pressures, tidal volume and leak during ventilation. During positive pressure ventilation in the delivery room, clinical signs are used to monitor the effectiveness of ventilation. The additional use of a respiratory function monitor during positive pressure ventilation in the delivery room might help to improve the effectiveness of ventilation.

Objectives

To determine whether the use of a respiratory function monitor in addition to clinical assessment compared to clinical assessment alone in newborn infants resuscitated with positive pressure ventilation reduces mortality and morbidity.

Search methods

We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 3, 2010), MEDLINE (January 1996 to March 2010), EMBASE (January 1980 to March 2010) and CINAHL (January 1982 to March 2010). Clinical trials registers and the abstracts of the Society for Pediatric Research and the European Society for Pediatric Research were searched from 2004 to 2009. No language restrictions were applied.

Selection criteria

We planned to include randomised and quasi-randomised controlled trials and cluster trials that compared the use of a respiratory function monitor in addition to clinical assessment, compared to clinical assessment alone, in newborn infants resuscitated with positive pressure ventilation.

Data collection and analysis

Two review authors independently evaluated the search results against the selection criteria. Data extraction and risk of bias assessment were not performed because there were no studies that met our inclusion criteria.

Results

No studies were found meeting the criteria for inclusion in this review

Authors' conclusions

There is insufficient evidence to determine the efficacy and safety of a respiratory function monitor in addition to clinical assessment during positive pressure ventilation at neonatal resuscitation. Randomised clinical trials comparing positive pressure ventilation with and without a respiratory function monitor in addition to clinical assessment at neonatal resuscitation are warranted.

Plain language summary

Respiratory function monitoring to reduce mortality and morbidity in newborn infants receiving resuscitation

When resuscitating a newborn baby, the team attending to the baby uses clinical judgement to determine how much assisted breathing is required during resuscitation. However, this approach is frequently inadequate. A respiratory function monitor measures the amount of air going into the babies lung. The clinical team can use this information to deliver better care to a newborn baby when assisted breathing alone is required. We were unable to identify any studies that compared the clinical judgement of assisted breathing with clinical judgement of assisted breathing plus the additional use of a respiratory function monitor to reduce mortality and morbidity in newborn infants receiving resuscitation.

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Background

Description of the condition

Approximately three to six percent of all newborn infants require respiratory assistance at birth (Singhal 2001). An internationally agreed consensus statement provides advice regarding techniques and equipment for neonatal resuscitation (International Liaison Committee on Resusc. 2005). Positive pressure ventilation (PPV) is commonly used in the delivery room (Singhal 2001) and is a cornerstone of neonatal resuscitation (Bennett 2005; O'Donnell 2004). The object of the first few inflations is to establish a functional residual capacity (FRC) and deliver an appropriate tidal volume (VT) to achieve effective gas exchange (te Pas 2008b).

Clinical signs including visible chest wall movements and increases in heart rate are used to monitor the effectiveness of ventilation techniques during neonatal resuscitation (International Liaison Committee on Resusc. 2005). This contrasts with neonatal intensive care units where ventilation is guided by respiratory function monitors that are built into all modern ventilators (Bhutani 2002; Keszler 2005; Klimek 2006; South 1986).

The delivered VT is usually not measured during neonatal resuscitation. Excessive VT can damage the lungs by overinflation (volutrauma) and insufficient VT will result in inadequate gas exchange (Bhutani 2002; Bjorklund 1996; Bjorklund 1997; Dreyfuss 1993; Dreyfuss 1998; Hillman 2007; Jobe 1998; Polglase 2008; Tremblay 2006; Vilstrup 1996; Wada 1997 ). Animal studies have shown that lung injury can occur during resuscitation with just a few large manual inflations (Bjorklund 1997). Dreyfuss (Dreyfuss 1985) demonstrated in a rat model that high tidal volumes rather than high pressures were responsible for lung injury. When the VT was controlled to prevent overdistention of the lungs, there was little or no injury. These animal and human observational data suggest that the VT during resuscitation should be within the range 4 to 8 mL/kg (Bjorklund 1997; Hillman 2007; Polglase 2008; Vilstrup 1996; Wada 1997). The delivered VT and, therefore, the optimum peak inflation pressure (PIP) will vary both between infants and in the same infant over time as the lung aerates, the infant starts to breathe and compliance and resistance change (Hooper 2007; te Pas 2008b).

Susceptibility to volutrauma as a result of excessive tidal volume delivery may be increased in more immature infants. Some observational studies of pulmonary function monitoring have been conducted in the delivery room (Menakaya 2004; te Pas 2008a; te Pas 2009; Tracy 2004). In an observational study, Menakaya 2004 compared a standard anaesthetic rebreathing circuit with volume guarantee ventilation using a Draeger ventilator during neonatal resuscitation. In both groups infants were overventilated and had mean tidal volumes of more than 9 mL/kg.

Research by te Pas and coworkers described different breathing patterns in preterm infants (te Pas 2008a) and the interactions between spontaneous breaths, manual ventilation and tidal volumes during stabilisation of infants with congenital diaphragmatic hernia (te Pas 2009).

Ventilation may be inadequate because of a leak between the mask and the face. This occurs frequently, even for experienced operators, and may be highly variable (O'Donnell 2005; Schmölzer 2010b; Wood 2008b; Wood 2008c). In studies using a mannequin, Wood and coworkers (Wood 2008a ) showed that mask leak could be halved if the resuscitator was able to see the VT and leak displayed by a respiratory function monitor.

Clinical assessment

During PPV the clinician should look at an increase in heart rate and observe chest wall movements to gauge effectiveness of ventilation. Rapid improvement of heart rate remains the primary clinical indicator of effective PPV. However, if heart rate does not increase, chest wall movements should be assessed to gauge adequacy of ventilation. If a manometer is used during PPV, clinicians can gauge the applied pressures. If the heart rate is not rising and the chest is not moving, the clinician may seek to improve mask position or increase the applied pressure (International Liaison Committee on Resusc. 2005). Clinicians require training in these procedures. This is usually provided by recognized training programs such as the Neonatal Resuscitation Program (USA) or the Newborn Life Support Course (United Kingdom).

Ventilation devices

The effectiveness of a respiratory function monitor (RFM) might vary depending on the type of ventilation device used.

Self-inflating bag

A self-inflating bag will re-expand following compression due to its own elastic recoil; a compressed gas source is not required to function, though one is usually attached to enhance oxygen delivery. The greatest advantage is the simplicity of use, particularly for the inexperienced operator. However, the same operator could be falsely reassured that a sufficient VT is being delivered when in reality, due to a large leak, it is not.

Flow-inflating bag

A flow-inflating (anaesthesia) bag requires a compressed gas source to inflate the bag during use. Large leaks at the facemask or too low flow will result in complete collapse of the bag and inability to deliver any tidal volume. While this makes operation technically more difficult, the operator’s attention is immediately drawn to large leaks. These devices can apply very high pressures and should only be used with a manometer and a blow off valve in the circuit (Bennett 2005; O'Donnell 2004).

T-piece mechanical device

A T-piece has a gas flow into the attached facemask, nasal prong or endotracheal tube through an “inlet” arm. Inflation is achieved by interrupting the escape of gas through the “outlet” hole with a finger. A safety blow-off valve is usually attached.

Skills and accreditation in the use of the listed devices is provided by recognized training programs such as the Neonatal Resuscitation Program (USA) or the Newborn Life Support Course (United Kingdom).

Interfaces

The effectiveness of a RFM might vary depending on the type of ventilation interface used. PPV might be performed using either a face mask, nasal prong or an endotracheal tube.

Face mask

A face mask attached to a ventilation device can be used to deliver PPV. A face mask will cover the mouth and nose of an infant which maybe is an advantage; however, achieving a good face mask seal is difficult (Schmölzer 2010a).

Nasal prong

Either a single prong or two prongs inserted a short distance into the nostrils and attached to a ventilation device can be used to deliver PPV.

Endotracheal tube

An internationally agreed consensus statement advises that PPV can be initiated using manual ventilation devices via a face mask (International Liaison Committee on Resusc. 2005); however, endotracheal intubation may be indicated to continue PPV.

Description of the intervention

A RFM measures and displays airway pressure, gas flow and tidal volume. A flow sensor is placed between the face mask or endotracheal tube and the ventilation device. The inspiratory and expiratory tidal volumes (VTi, VTe) passing through the sensor are automatically calculated by integrating the flow signal. In addition, the percentage of leak between mask and face or around an endotracheal tube (ETT) is calculated and displayed with the following equation: [(VTiVTe) ÷ VTi] x 100. An airway pressure monitoring line is connected to measure and display Peak Inflation Pressure (PIP) and Positive End Expiratory Pressure (PEEP) (Schmölzer 2010a).

It is unclear whether similar benefits will be observed and outcomes following resuscitation improved if a RFM is used in the delivery room in conjunction with the standard techniques of clinical assessment.

We planned to include studies evaluating all commercially available RFMs (e.g. Florian Neonatal Respiratory Function Monitor, Acutronic Medical Systems AG, Zug, Switzerland; Respironics NICO and NICO2 Philips, Amsterdam, Netherlands; CO2SMO, Novametrix Inc., Wallingford, CT, USA). Any studies evaluating similar devices were also to be included in the review. All of these devices are applicable to patients of different size (e.g. neonates, children, adults).

  • A Florian Neonatal Respiratory Monitor (Acutronic Medical Systems AG, Zug, Switzerland) continuously displays pressure, flow and tidal volume waves. It also measures and displays numerical values for PIP, PEEP, VTi, VTe, respiratory rate (RR), expiratory minute ventilation (MVe) and displays the percentage of the leak between mask and face or around an ETT.
  • A Respironics NICO2 Monitor (Philips, Amsterdam, Netherlands) continuously measures and displays numerical values for VTe, RR, alveolar minute volume (MValv), PIP and PEEP.
  • The pneumotachograph CO2SMO, (Novametrix Inc., Wellingford, CT, USA) continuously measures and displays numerical values for VT, RR, PIP and PEEP.

The displayed information as well as the design of the screen are the major differences between all available RFMs. These differences might have an effectiveness on the feedback to the resuscitator during PPV. Inexperience and lack of knowledge about the displayed waveforms may lead to misinterpretation of the signals. Therefore, anyone using a RFM must be trained to interpret pressure, flow and tidal volume signals (Schmölzer 2010a). Likewise, resuscitation using clinical signs (with or without the RFM) should be performed by an operator trained in the techniques.

How the intervention might work

A RFM may be applied during PPV in the delivery room. The resuscitator receives real-time measures of delivered tidal volume, applied airway pressure and gas leak. During PPV the resuscitator is able to see a RFM that displays waveforms and numerical values of VT, PIP, gas flow, RR or percentage of mask leak. Using this information in addition to clinical assessment, the clinician can alter face mask position to reduce face mask leak as well as observe the delivered tidal volume to adjust the delivered PIP (Schmölzer 2010a).

Failure of ventilation may be due to a big leak either around the face mask or ETT. A RFM displays any leak; hence, the resuscitator can alter the face mask position and optimise face mask hold or change to a larger diameter ETT if the leak is big and no effective ventilation occurs (Schmölzer 2010a).

During PPV the compliance and, therefore, the delivered tidal volume varies. In order to maintain a constant tidal volume the applied pressure has to be adjusted. A RFM displays the delivered tidal volume, so that the resuscitator then can alter the delivered pressure by either squeezing a flow- or self-inflating bag harder or alter the pressure dial on a T-piece resuscitator.

Why it is important to do this review

In spite of improvements in neonatal resuscitation, some infants die and some survive with cognitive impairments. Experts have suggested that the techniques used in the neonatal intensive care unit to monitor heart rate, oxygen saturation and tidal volume should be applied during neonatal resuscitation (Kattwinkel 2009; Schmölzer 2010a; Vento 2008a; Vento 2008b). Instituting such practice may help to improve survival rate and reduce neurodevelopmental morbidity of term and preterm infants (Vento 2008a; Vento 2008b). This review aims to summarise the evidence from randomised controlled trials related to the use of a RFM during neonatal resuscitation. The results from this review will highlight gaps in the evidence base and assist in the identification of best practice.

Objectives

To determine the effect of using a respiratory function monitor in addition to clinical assessment, compared to clinical assessment alone, on mortality and morbidity in newborn infants resuscitated with positive pressure ventilation.

Further subgroup analysis was planned to determine whether the safety and efficacy vary according to:

  • Gestational age: Term (37 weeks' gestation and above) vs. preterm between 29 and 36 weeks vs. preterm < 29 weeks infants
  • Interface for delivering positive pressure ventilation: Mask vs. single nasal prong vs. endotracheal tube
  • Ventilation device for delivering positive pressure ventilation: Self-inflating bag vs. flow-inflating bag vs. T-piece device
  • Type of Respiartory Function Monitor: Subgroup analysis based on the model of the RFM

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Methods

Criteria for considering studies for this review

Types of studies

All randomised and quasi-randomised controlled trials available as abstracts or peer-reviewed manuscripts were to be included. Cluster trials were to be individually examined and, if possible, included in the same meta-analysis.

Types of participants

Term and preterm infants resuscitated using a RFM in addition to clinical assessment compared to clinical assessment alone.

Types of interventions

Positive pressure ventilation with a RFM visible versus positive pressure ventilation where the operator is blinded to the display of the RFM. Inexperience and lack of knowledge about the displayed waveforms may lead to misinterpretation of the signals. Therefore, anyone using a RFM must be trained to interpret pressure, flow and tidal volume signals. Likewise, resuscitation using clinical signs (with or without the RFM) should be performed by an operator trained in the techniques. For the purposes of this review, only studies where clinical staff were trained in both resuscitation and the use of a RFM were considered eligible for inclusion.

Types of outcome measures

Primary outcomes
  • Neonatal death < 28 days.
  • Death before discharge.
Secondary outcomes
  • Percentage leak during positive pressure ventilation with any interface (e.g. face mask, nasal prong).
  • Tidal volume (in mL/kg) during positive pressure ventilation with any interface (face mask, nasal prong, endotracheal tube).
  • Apgar score at one and five minutes.
  • Heart rate (beats per minute) at five minutes.
  • Oxygen saturation (%) at one and five minutes.
  • Endotracheal intubation in the delivery room.
  • Endotracheal intubation in the neonatal intensive care unit during hospitalisation.
  • Air leaks (pneumothorax, pneumomediastinum, pneumopericardium, pulmonary interstitial emphysema) reported either individually or as a composite outcome.
  • Duration of supplemental oxygen requirement (number of days).
  • Duration of respiratory support, i.e. nasal continuous airway pressure and ventilation via an endotracheal tube considered separately and in total (number of days).
  • Chronic lung disease: Need for supplemental oxygen at 28 days of life; need for supplemental oxygen at 36 weeks postmenstrual age for infants born at or before 32 weeks gestation.
  • Cranial ultrasound abnormalities: Any intraventricular haemorrhage (IVH) grade 3 or 4 according to Papile classification (Papile 1978) and cystic periventricular leukomalacia.
  • Seizures including clinical and electroencephalographic.
  • Hypoxic ischaemic encephalopathy (Grade I-III; Sarnat 1976).

Search methods for identification of studies

We used the standard methods of the Cochrane Neonatal Review Group guidelines.

Electronic searches

We searched the Cochrane Central Register of Controlled Trials (CENTRAL, in The Cochrane Library, Issue 3, 2010), MEDLINE via PubMed (January 1996 to March 2010), EMBASE (January 1980 to March 2010) and CINAHL (January 1982 to March 2010) using the search terms Infant, Newborn, Resuscitation, Positive Pressure Respiration, Respiratory Function Tests and Monitoring, physiologic. All languages were included. The full search strategies used are detailed in Appendix 1.

Searching other resources

Published abstracts: The abstracts of the Society for Pediatric Research from 2004 to 2009 were searched electronically through the PAS web site (abstractsonline). Clinical trials registries were also searched for ongoing or recently completed trials (ClinicalTrials.gov, Controlled-Trials.com External Web Site Policy, and WHO International Clinical Trials Registry Platform (ICTRP) External Web Site Policy). The results of the search of trials registries are detailed in Appendix 2.

Data collection and analysis

We used the standard methods of the Cochrane Neonatal Review Group guidelines.

Selection of studies

We planned for each review author to independently select studies for inclusion, based on the criteria set out above, by screening the titles and abstracts obtained through the searches. We planned to obtain the full text articles in cases where studies appeared to be eligible for inclusion. Disagreements were to be resolved by discussion. All randomised and quasi-randomised controlled studies as well as cluster trials fulfilling the described in the previous section were included.

Data extraction and management

We planned for each review author to independently assess methodology and extract data followed by comparison of results and discussion to resolve any differences found at each stage. Assessment of methodology regarding blinding of randomisation, intervention and outcome measurements as well as completeness of follow-up was planned.

Assessment of risk of bias in included studies

We planned to independently review the methodological quality of each trial including assessment of a) masking of allocation; b) masking of intervention; c) completeness of follow-up; and d) masking of outcome assessment.This information was to be included in the 'Characteristics of Included Studies' table.

In addition, we planned to complete the Risk of Bias table addressing the following methodological issues:

  1. Sequence generation: Was the allocation sequence adequately generated?
    1. For each included study, we planned to describe the method used to generate the allocation sequence as: adequate (any truly random process, e.g. random number table; computer random number generator); inadequate (any nonrandom process, e.g. odd or even date of birth; hospital or clinic record number); or unclear.
  2. Allocation concealment: Was allocation adequately concealed?
    1. For each included study, we planned to describe the method used to conceal the allocation sequence as: adequate (e.g. telephone or central randomisation; consecutively numbered sealed opaque envelopes); inadequate (open random allocation; unsealed or non-opaque envelopes, alternation; date of birth); or unclear.
  3. Blinding of participants, personnel and outcome assessors: Was knowledge of the allocated intervention adequately prevented during the study? At study entry? At the time of outcome assessment?
    1. For each included study, we planned to describe the methods used to blind study participants and personnel from knowledge of which intervention a participant received. We planned to assess the methods as: adequate, inadequate or unclear for participants; adequate, inadequate or unclear for study personnel; and adequate, inadequate or unclear for outcome assessors and specific outcomes assessed.
  4. Incomplete outcome data: Were incomplete outcome data adequately addressed?
    1. For each included study and for each outcome, we planned to describe the completeness of data including attrition and exclusions from the analysis. We planned to address whether attrition and exclusions were reported, the numbers included in the analysis at each stage (compared with the total randomised participants), reasons for attrition or exclusion where reported, and whether missing data were balanced across groups or were related to outcomes. We planned to assess methods as: adequate (less than/or equal to 20% missing data); inadequate (> 20% missing data) or unclear.
  5. Selective outcome reporting: Are reports of the study free of suggestion of selective outcome reporting?
    1. For each included study, we planned to assess the possibility of selective outcome reporting bias as: adequate (where it is clear that all of the study's pre-specified outcomes and all expected outcomes of interest to the review have been reported); inadequate (where not all the study's pre-specified outcomes have been reported; one or more reported primary outcomes were not pre-specified; outcomes of interest are reported incompletely and so cannot be used; study fails to include results of a key outcome that would have been expected to have been reported); or unclear.
  6. Other sources of bias: Was the study apparently free of other problems that could put it at a high risk of bias?
    1. For each included study, we planned to note any important concerns regarding other possible sources of bias (e.g. whether there was a potential source of bias related to the specific study design or whether the trial was stopped early due to some data-dependent process). We planned to assess whether each study was free of other problems that could put it at risk of bias as: yes; no; or unclear.

Measures of treatment effect

We planned to evaluate the treatment effect using a fixed-effect model as follows:

  • categorical data using relative risk (RR), relative risk reduction, risk difference (RD) and number needed to treat (NNT);
  • continuous data using mean and standard deviation and weight mean difference;
  • the 95% confidence interval (CI) for each measure of effect;
  • for cluster trials, analysis at the level of the individual while accounting for the clustering.

Assessment of heterogeneity

We planned to apply tests for between study heterogeneity including the I2 test to assess the statistical heterogeneity. If heterogeneity was identified, we planned to perform further analyses to identify the cause.

Data synthesis

If multiple studies were identified, we planned to perform meta-analysis using Review Manager 5 (RevMan) software. For estimates of typical relative risk and risk difference, we planned to use the Mantel-Haenszel method. For measured quantities, we planned to use the inverse variance method. We planned to conduct all meta-analyses using the fixed-effect model.

Subgroup analysis and investigation of heterogeneity

We planned to perform the following subgroup analyses:

  • gestational age < 29 weeks, 29 to 36 weeks, 37 weeks and above;
  • ventilation device used (self-inflating bag, flow-inflating bag, T-piece, mechanical ventilator);
  • patient interface used (face mask, endotracheal tube, nasopharyngeal tube);
  • specific respiratory function monitors.

Sensitivity analysis

We planned to perform sensitivity analyses to evaluate the effect of trial quality. We planned to define high quality trials as those having adequate randomisation and allocation concealment, blinded measurement of outcomes and < 10% losses to follow up in intention-to-treat analysis.

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Results

Description of studies

The initial search identified 34 abstracts. Of these, we identified one as potentially relevant. However, on closer inspection, it did not meet the inclusion criteria for this review.

Results of the search

No studies were found meeting the criteria for inclusion in this review. One ongoing trial was found comparing a RFM either visible or covered during PPV in preterm infants less than/or equal to 32 weeks gestation.

Included studies

No studies were found meeting the criteria for inclusion in this review.

Excluded studies

One ongoing trial was found comparing a RFM either visible or covered during PPV in preterm infants less than/or equal to 32 weeks gestation. Each infant requiring PPV at birth will have a flow sensor placed between the ventilation device and the face mask. The clinical team will have either a RFM visible or masked to assist with the clinical judgement. The primary outcomes of this trial are a reduction in face mask leak and reduction in tidal volume delivery.

See: Characteristics of ongoing studies.

Risk of bias in included studies

No studies met the criteria for inclusion in this review.

Effects of interventions

No studies met the criteria for inclusion in this review.

Discussion

We found no randomised or quasi-randomised controlled trials addressing the use of a respiratory function monitor in addition to clinical assessment compared to clinical assessment alone during neonatal resuscitation, thus, this systematic review does not establish whether its use reduces mortality and morbidity, or results in harm. We conclude that the additional use of a respiratory function monitor in this context is based only on evidence derived from mannequin studies (O'Donnell 2005; Wood 2008a; Wood 2008c) and observational studies (Schmölzer 2010a; Schmölzer-2010b). Future studies should enrol both term and preterm infants who require positive pressure ventilation at birth. Important outcomes would include those specified in our criteria for considering studies for this review.

Summary of main results

No studies met the criteria for inclusion in this review.

Overall completeness and applicability of evidence

There is insufficient evidence to determine the efficacy and safety of a respiratory function monitor in addition to clinical assessment during positive pressure ventilation at neonatal resuscitation.

Quality of the evidence

There is insufficient evidence to determine the efficacy and safety of a respiratory function monitor in addition to clinical assessment during positive pressure ventilation at neonatal resuscitation.

Potential biases in the review process

No studies met the criteria for inclusion in this review.

Agreements and disagreements with other studies or reviews

No studies met the criteria for inclusion in this review.

Authors' conclusions

Implications for practice

There is insufficient evidence to determine the efficacy and safety of a respiratory function monitor in addition to clinical assessment during positive pressure ventilation at neonatal resuscitation.

Implications for research

Randomised clinical trials comparing positive pressure ventilation with and without a respiratory function monitor in addition to clinical assessment at neonatal resuscitation are warranted.

Acknowledgements

The Cochrane Neonatal Review Group has been funded in part with Federal funds from the Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health, Department of Health and Human Services, USA, under Contract No. HHSN267200603418C.

Contributions of authors

Dr. Georg Schmölzer and Prof. Peter Davis performed the literature search. Dr. Georg Schmölzer wrote the manuscript, which was reviewed by Prof. Peter Davis and Prof. Colin Morley.

Declarations of interest

Dr. Georg Schmölzer is an investigator for the ongoing study cited in this review (Schmölzer-2010a).

Potential conflict of interest

  • None noted.

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Characteristics of studies

Characteristics of Included Studies

  • None noted.

Characteristics of excluded studies

  • None noted.

Characteristics of studies awaiting classification

  • None noted.

Characteristics of ongoing studies

Schmölzer 2010

Study name

In extremely low birth weight (ELBW) infants who require positive pressure ventilation at birth, does the use of a respiratory function monitor reduce face mask leak and improve the target tidal volume in the first ten minutes of life?

Methods

A randomised controlled trial of a respiratory function monitor during positive pressure ventilation during resuscitation of infants. A flow sensor will be placed between the mask and the Neopuff T-piece-device. This flow sensor measures the airflow and calculates the tidal volume. Each infant requiring positive pressure ventilation at birth will be recorded with the flow sensor in place. The duration of this recording will last during the initial stabilisation in the delivery room.

Participants

Preterm infants less than/or equal to 32 weeks gestation

Interventions

Intervention: In the intervention group the respiratory function monitor is visible, so that the resuscitator can see the display of the respiratory function monitor to alter their technique and adjust the delivered tidal volume.

Control: In the comparator group the respiratory function monitor is masked, so that the resuscitator cannot see the display or hear any alarms of the respiratory function monitor.

Outcomes
  • Reduction of face mask leak during positive pressure ventilation
  • Difference in the delivered tidal volume
  • Changes in heart rate in the first ten minutes of life
  • Changes in oxygen saturation in the first ten minutes of life
  • Rate of intubation in the delivery room
  • Total days of ventilation support during hospital stay
  • Total days of respiratory (ventilation, continuous positive airways pressure (CPAP), oxygen) support during hospital stay
  • Oxygen treatment at 36 weeks gestational age
Starting date

11/11/2008

Contact information

Dr. Georg Schmölzer
Department of Newborn Research
The Royal Women's Hospital
20 Flemington Road, Parkville, 3052, Victoria,
Australia
Email: georg.schmoelzer@me.com
Tel: +61 (0)3 8345 - 3775
Fax: +61 (0)3 8345 - 3789

Notes

Update: Recruitment completed

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References to studies

Included studies

  • None noted.

References to excluded studies

  • None noted.

Studies awaiting classification

  • None noted.

Ongoing studies

  • None noted.

Other references

Additional references

Bennett 2005

Bennett S, Finer NN, Rich W, Vaucher Y. A comparison of three neonatal resuscitation devices. Resuscitation 2005;67(1):113-8.

Bhutani 2002

Bhutani VK. Clinical applications of pulmonary function and graphics. Seminars in Neonatology 2002;7(5):391-9.

Bjorklund 1996

Bjorklund LJ, Vilstrup CT, Larsson A, Svenningsen NW, Werner O. Changes in lung volume and static expiratory pressure-volume diagram after surfactant rescue treatment of neonates with established respiratory distress syndrome. American Journal of Respiratory and Critical Care Medicine 1996;154(4 Pt 1):918-23.

Bjorklund 1997

Bjorklund LJ, Ingimarsson J, Curstedt T, John J, Robertson B, Werner O, et al. Manual ventilation with a few large breaths at birth compromises the therapeutic effect of subsequent surfactant replacement in immature lambs. Pediatric Research 1997;42(3):348-55.

Dreyfuss 1985

Dreyfuss D, Basset G, Soler P, Saumon G. Intermittent positive-pressure hyperventilation with high inflation pressures produces pulmonary microvascular injury in rats. American Review of Respiratory Disease 1985;132(4):880-4.

Dreyfuss 1993

Dreyfuss D, Saumon G. Role of tidal volume, FRC, and end-inspiratory volume in the development of pulmonary edema following mechanical ventilation. American Review of Respiratory Disease 1993;148(5):1194-203.

Dreyfuss 1998

Dreyfuss D, Saumon G. Ventilator-induced lung injury: lessons from experimental studies. American Journal of Respiratory and Critical Care Medicine 1998;157(1):294-323.

Hillman 2007

Hillman NH, Moss TJ, Kallapur SG, Bachurski C, Pillow JJ, Polglase GR, et al. Brief, large tidal volume ventilation initiates lung injury and a systemic response in fetal sheep. American Journal of Respiratory and Critical Care Medicine 2007;176(6):575-81.

Hooper 2007

Hooper SB, Kitchen MJ, Wallace MJ, Yagi N, Uesugi K, Morgan MJ, et al. Imaging lung aeration and lung liquid clearance at birth. FASEB Journal 2007;21(12):3329-37.

International Liaison Committee on Resusc. 2005

International Liaison Committee on Resuscitation. 2005 International consensus on cardiopulmonary resuscitation and emergency cardiovascular care science with treatment recommendations. Part 7: Neonatal resuscitation. Resuscitation 2005;67(2-3):293-303.

Jobe 1998

Jobe AH, Ikegami M. Mechanisms initiating lung injury in the preterm. Early Human Development 1998;53(1):81-94.

Kattwinkel 2009

Kattwinkel J, Stewart C, Walsh B, Gurka M, Paget-Brown A. Responding to compliance changes in a lung model during manual ventilation: perhaps volume, rather than pressure, should be displayed. Pediatrics 2009;123(3):e465-70.

Keszler 2005

Keszler M. Volume-targeted ventilation. Journal of Perinatology 2005;25(Suppl 2):S19-22.

Klimek 2006

Klimek J, Morley CJ, Lau R, Davis PG. Does measuring respiratory function improve neonatal ventilation? Journal of Paediatrics and Child Health 2006;42(3):140-2.

Menakaya 2004

Menakaya J, Andersen C, Chirla D, Wolfe R, Watkins A. A randomised comparison of resuscitation with an anaesthetic rebreathing circuit or an infant ventilator in very preterm infants. Archives of Disease in Childhood. Fetal and Neonatal Edition 2004;89(6):F494-6.

O'Donnell 2004

O'Donnell CP, Davis PG, Morley CJ. Positive pressure ventilation at neonatal resuscitation: review of equipment and international survey of practice. Acta Paediatrica 2004;93(5):583-8.

O'Donnell 2005

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Data and analyses

  • None noted.

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Sources of support

Internal sources

  • The Royal Women's Hospital, Australia
  • University of Melbourne, Australia
  • Monash University, Australia

External sources

  • Murdoch Childrens Research Institute, Australia
  • National Health and Medical Research Council, Australia
  • Medical University Graz, Austria

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Feedback

  • None noted.

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Appendices

1 Search strategies

Search strategy for MEDLINE/PubMed

Limits activated: Humans, Clinical Trial, Randomized Controlled Trial, Clinical Trial, Phase I, Clinical Trial, Phase II, Clinical Trial, Phase III, Clinical Trial, Phase IV, Controlled Clinical Trial, All Infant: birth-23 months, All Child: 0-18 years, Newborn: birth-1 month, Infant: 1-23 months, Publication Date from 1996/01/01 to 2010/06/20

  1. MeSH descriptor Infant explode all trees (Result: 23, 584)
  2. MeSH descriptor Newborn explode all trees (Result: 11, 117)
  3. MeSH descriptor Resuscitation explode all trees (Result: 1, 101)
  4. (#1 OR #2) AND #3 (Result: 702)
  5. MeSH descriptor Positive Pressure Respiration explode all trees (Result: 401)
  6. MeSH descriptor Respiratory Function Tests explode all trees (Result: 3, 651)
  7. MeSH descriptor Monitoring, physiologic all trees (Result: 1, 947)
  8. #5 AND (#6 OR #7) (Result: 188)
  9. (#4 AND #8) (Result: 34 ; Number needed to read the full article 1)

Search strategy for EMBASE

Limits activated: ([controlled clinical trial]/lim OR [randomized controlled trial]/lim) AND ([newborn]/lim OR [infant]/lim OR [preschool]/lim OR [child]/lim) AND [humans]/lim AND [1980-2010]/py

  1. 'infant'/exp OR infant (Result: 13, 597)
  2. 'newborn'/exp OR newborn (Result: 9, 121)
  3. 'resuscitation'/exp OR resuscitation (Result: 176)
  4. (#1 OR #2) AND #3 (Result: 129)
  5. positive AND ('pressure'/exp OR pressure) AND ('respiration'/exp OR respiration) (Result: 278)
  6. respiratory AND function AND tests (Result: 1, 22)
  7. monitoring, AND physiologic (Result: 33)
  8. #5 AND (#6 OR #7) (Result: 15)
  9. #4 AND #8 (Result: 0)

Search strategy for CINAHL

Limits activated: Human, 01/1982 - 05/2010, Infant, Newborn: birth - 1month

  1. (MH “Infant”) (Result: 52, 185)
  2. (MH “Newborn”) (Result: 52, 185)
  3. (MH “Resuscitation”) (Results 1, 029)
  4. (S1 or S2) AND S3 (Result: 1, 031)
  5. (MH “Positive Pressure Respiration”) (Result: 2)
  6. (MH “Respiratory Function Tests”) (Result: 100)
  7. (MH "Monitoring, physiologic") (Result: 198)
  8. S5 and (S6 OR S7) (Result: 0)
  9. S4 and S8 (Result: 0)

Search strategy for CENTRAL, The Cochrane Library

  1. MeSH descriptor Infant explode all trees (Result: 9, 243)
  2. MeSH descriptor Newborn explode all trees (Result: 9, 240)
  3. MeSH descriptor Resuscitation explode all trees (Result: 2, 505)
  4. #1 AND #3 (Result: 471)
  5. MeSH descriptor Positive Pressure Respiration explode all trees (Result: 1, 371)
  6. MeSH descriptor Respiratory Function Tests explode all trees (Result: 16, 698)
  7. MeSH descriptor physiologic Monitoring explode all trees (Result: 6, 569)
  8. #6 AND (#7 OR #8) (Result: 730)
  9. (#4 AND #8) (Result: 17) (Number needed to read the full article 1)

2 Trials registries

Search strategy for International Clinical Trial Registry Platform (ICTRP) External Web Site Policy

  1. #1 Infant OR Newborn AND Resuscitation AND Positive Pressure Respiration - Result: 4
  2. #2 Infant OR Newborn AND Resuscitation AND Respiratory Function Tests - Result: 0
  3. #3 Infant OR Newborn AND Resuscitation AND physiologic Monitoring - Result: 0

Search strategy for Clinical Trials

  1. Infant OR Newborn AND Resuscitation AND Positive Pressure Respiration - Result: 3 and 1 terminated
  2. Infant OR Newborn AND Resuscitation AND Respiratory Function Tests - Result:
  3. Infant OR Newborn AND Resuscitation AND physiologic Monitoring - Result: 0

Search strategy for Current Controlled Trials External Web Site Policy

  1. Infant OR Newborn AND Resuscitation AND Positive Pressure Respiration - Result: 0
  2. Infant OR Newborn AND Resuscitation AND Respiratory Function Tests - Result: 0
  3. Infant OR Newborn AND Resuscitation AND physiologic Monitoring - Result: 0

This review is published as a Cochrane review in The Cochrane Library, Issue 9, 2010 (see http://www.thecochranelibrary.com External Web Site Policy for information). Cochrane reviews are regularly updated as new evidence emerges and in response to feedback. The Cochrane Library should be consulted for the most recent version of the review.