Use of CO2 Detectors to Help Provide Effective Breaths During Resuscitation of Preterm Newborns

Study Overview
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Brief Summary
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Effective ventilation is the single most vital intervention to improve outcome of resuscitation in the neonatal population. Assessments of effective ventilations are based on clinical parameters, but may be difficult due to inexperienced personnel as well as observer variability. End tidal CO2 detectors (ETCO2) have been shown to improve effective ventilation in manikin model as well as in video recordings of selective infants where obstructive breaths were recognized objectively by means of lack of colour change. This is a trial evaluating the use of a qualitative end tidal CO2 monitor device during mask ventilation in the delivery room. The investigators hypothesize that using a colorimetric carbon dioxide detector during mask ventilation, it could facilitate recognition of obstructed breaths and reduce the duration of bradycardia and desaturations.

Official Title
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The Utility of Qualitative End Tidal CO2 Detector in Providing Effective Ventilation During Resuscitation of Preterm Newborns: A Pilot Randomized Controlled Trial

Conditions
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Preterm Birth

Intervention / Treatment
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* Device: Monitor Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants 24+0/7 to 32+0/7 weeks who require mask ventilation during resuscitation Exclusion Criteria: Infants with impaired pulmonary circulation (eg. Cardiac arrest, pulmonary atresia, severe pulmonary stenosis Infants with congenital airway anomalies

Ages Eligible for Study
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Maximum Age: 60 Minutes

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monitor<br>Qualitative End Tidal Co2 detector will be attached to the face mask used to provide mask ventilation to the preterm baby before connected to the T piece resuscitator. Respiratory function monitor sensor will be placed within circuit to measure parameters e.g. PIP, PEEP, FiO2, tidal volume. | Device: Monitor Group<br>* Use of colorimetric end tidal CO2 to guide provider during provision of mask ventilation, where colour change indicates effective breaths<br>|
| No Intervention: Control<br>face mask used to provide mask ventilation to the preterm baby will be connected directly to the T piece resuscitator. Respiratory function monitor sensor will be placed within circuit to measure parameters e.g. PIP, PEEP, FiO2, tidal volume. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bradycardia and Desaturation Duration | Duration of bradycardia (HR<100beats per minute) + Desaturation (SpO2 readings below recommended target during respective minutes of life after birth | This outcome will be obtained immediately after birth when available on pulse oximetry | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery room intubation | This outcome will be counted as yes if infant required endotracheal intubation in the delivery room | During resuscitation course at birth | 
| Delivery room chest compressions | This outcome will be counted as yes if infant required chest compressions in the delivery room | During resuscitation course at birth | 
| Delivery room peak inspiratory pressure (PIP) | Peak inspiratory pressure (PIP) used during mask ventilation during resuscitation after birth, measured as cmH20 | During resuscitation course at birth | 
| Delivery room positive end expiratory pressure (PEEP) | Positive end expiratory pressure (PEEP) used during mask ventilation during resuscitation after birth, measured as cmH20 | During resuscitation course at birth | 
| Delivery room fraction of inspired oxygen level (FiO2) | Fraction of inspired oxygen level (FiO2) measured using an oxygen analyser within the ventilating circuit during mask ventilation (ranges from 0.21-1.0) | During resuscitation course at birth | 
| Tidal volume during resuscitation | Tidal volume (ml/kg) measured using a respiratory function monitor sensor attached to the mask during mask ventilation | During resuscitation course at birth | 
| Mask leakage during resuscitation | mask leakage (%) measured and calculated using a respiratory function monitor during mask ventilation | During resuscitation course at birth | 
| Apgar Scores | Apgar score with a scale of 0-10 (0 being the worst and 10 the best) obtained by adding points for heart rate, respiratory effort, muscle tone, reflex, and colour to represent the condition of newborn baby after birth. Scores are assigned at at 1 and 5 minutes of life respectively, with extension after 10 minutes if initial scores are low | During resuscitation course at birth | 
| Admission blood gas partial pressure of carbon dioxide (pCO2) levels | first blood gas pCO2 levels in mmHg | During inpatient hospital course, usually 2-3 months | 
| Occurrence of air leak syndromes | pneumothorax, pneumomediastinum confirmed on x ray | During inpatient hospital course, usually 2-3 months | 
| Duration of assisted ventilation before discharge | ventilation days on mechanical ventilator or continuous positive airway pressure (CPAP) respectively | During inpatient hospital course, usually 2-3 months | 
| incidence of severe intraventricular hemorrhage (IVH) | ultrasound finding of grade3-4 intraventricular hemorrhage | During inpatient hospital course, usually 2-3 months | 
| incidence of necrotizing enterocolitis (NEC) | diagnosis of NEC proven by abdominal X-rays, classified as Bell Stage II | During inpatient hospital course, usually 2-3 months | 
| incidence of chronic lung disease (CLD) | diagnosed when there is a need for oxygen at 36 weeks post menstrual age | During inpatient hospital course, usually 2-3 months | 
| incidence of severe retinopathy of prematurity (ROP) | diagnosed when there is a need for laser surgery for treatment of ROP | During inpatient hospital course, usually 2-3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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end tidal carbon dioxide, mask ventilation, neonatal resuscitation