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

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04287907
• Other study ID #: 2016/2405
• Status: Completed
• Phase: N/A
• Start date: June 6, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2023
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 30, 2022
• Est. primary completion date: April 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 60 Minutes

Eligibility

Inclusion Criteria:

Preterm infants 24+0/7 to 32+0/7 weeks who require mask ventilation during resuscitation

Exclusion Criteria:

1. Infants with impaired pulmonary circulation (eg. Cardiac arrest, pulmonary atresia, severe pulmonary stenosis

2. Infants with congenital airway anomalies

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Device:
• Monitor Group
Use of colorimetric end tidal CO2 to guide provider during provision of mask ventilation, where colour change indicates effective breaths

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (3)

Finer NN, Rich W, Wang C, Leone T. Airway obstruction during mask ventilation of very low birth weight infants during neonatal resuscitation. Pediatrics. 2009 Mar;123(3):865-9. doi: 10.1542/peds.2008-0560. — View Citation

Hawkes GA, Finn D, Kenosi M, Livingstone V, O'Toole JM, Boylan GB, O'Halloran KD, Ryan AC, Dempsey EM. A Randomized Controlled Trial of End-Tidal Carbon Dioxide Detection of Preterm Infants in the Delivery Room. J Pediatr. 2017 Mar;182:74-78.e2. doi: 10.1016/j.jpeds.2016.11.006. Epub 2016 Dec 9. — View Citation

Leone TA, Lange A, Rich W, Finer NN. Disposable colorimetric carbon dioxide detector use as an indicator of a patent airway during noninvasive mask ventilation. Pediatrics. 2006 Jul;118(1):e202-4. doi: 10.1542/peds.2005-2493. Epub 2006 Jun 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of corrective measures performed	Number of corrective measures performed to overcome ineffective mask ventilation observed on video recording of resuscitation	During resuscitation at birth
Primary	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	Delivery room intubation	This outcome will be counted as yes if infant required endotracheal intubation in the delivery room	During resuscitation course at birth
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mask leakage during resuscitation	mask leakage (%) measured and calculated using a respiratory function monitor during mask ventilation	During resuscitation course at birth
Secondary	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
Secondary	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
Secondary	Occurrence of air leak syndromes	pneumothorax, pneumomediastinum confirmed on x ray	During inpatient hospital course, usually 2-3 months
Secondary	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
Secondary	incidence of severe intraventricular hemorrhage (IVH)	ultrasound finding of grade3-4 intraventricular hemorrhage	During inpatient hospital course, usually 2-3 months
Secondary	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
Secondary	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
Secondary	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