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

NCT04287907 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-10-04

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Monitor Group

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

Sponsors & Collaborators

  • KK Women's and Children's Hospital

    lead OTHER_GOV

Principal Investigators

  • Juin Yee Kong, MD · KK Women's and Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
60 Minutes
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-06
Primary Completion
2021-04-10
Completion
2022-06-30

Countries

  • Singapore

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04287907 on ClinicalTrials.gov