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

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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Birth
• Intervention / Treatment: Device: Monitor Group

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 229899
    • KK Women's and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 hour (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monitor; 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; Use of colorimetric end tidal CO2 to guide provider during provision of mask ventilation, where colour change indicates effective breaths
No Intervention: Control; 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?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital
• Investigators: Principal Investigator: Juin Yee Kong, MD, KK Women's and Children's Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2019
• Primary Completion (Actual): April 10, 2021
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: neonatal resuscitation; end tidal carbon dioxide; mask ventilation
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: 2016/2405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No