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

KK Women's and Children's Hospital

Status: Completed

Conditions: Preterm Birth

Treatments: Device: Monitor Group

Study type: Interventional

Funder types: Other

Identifiers

NCT04287907

2016/2405

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: Under 60 minutes old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Monitor

Experimental group

Description:

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.

Treatment:

Device: Monitor Group

Control

No Intervention group

Description:

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.