The Utility of Qualitative End Tidal CO2 Detector in Providing Effective Ventilation During Resuscitation of Preterm Newborns: A Pilot Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Bradycardia and Desaturation Duration
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 60 Minutes (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Bradycardia and Desaturation Duration
Time Frame: This outcome will be obtained immediately after birth when available on pulse oximetry
Duration of bradycardia (HR\<100beats per minute) + Desaturation (SpO2 readings below recommended target during respective minutes of life after birth
Secondary Outcomes
- Delivery room chest compressions(During resuscitation course at birth)
- Delivery room intubation(During resuscitation course at birth)
- Delivery room peak inspiratory pressure (PIP)(During resuscitation course at birth)
- Delivery room fraction of inspired oxygen level (FiO2)(During resuscitation course at birth)
- Delivery room positive end expiratory pressure (PEEP)(During resuscitation course at birth)
- incidence of severe intraventricular hemorrhage (IVH)(During inpatient hospital course, usually 2-3 months)
- Apgar Scores(During resuscitation course at birth)
- Duration of assisted ventilation before discharge(During inpatient hospital course, usually 2-3 months)
- incidence of chronic lung disease (CLD)(During inpatient hospital course, usually 2-3 months)
- Admission blood gas partial pressure of carbon dioxide (pCO2) levels(During inpatient hospital course, usually 2-3 months)
- incidence of necrotizing enterocolitis (NEC)(During inpatient hospital course, usually 2-3 months)
- incidence of severe retinopathy of prematurity (ROP)(During inpatient hospital course, usually 2-3 months)
- Tidal volume during resuscitation(During resuscitation course at birth)
- Mask leakage during resuscitation(During resuscitation course at birth)
- Occurrence of air leak syndromes(During inpatient hospital course, usually 2-3 months)
Investigators
Kong Juin Yee
Consultant Neonatologist
KK Women's and Children's Hospital