Use of CO2 Detectors to Help Provide Effective Breaths During Resuscitation of Preterm Newborns
- Conditions
- Preterm Birth
- Interventions
- Device: Monitor Group
- Registration Number
- NCT04287907
- Lead Sponsor
- KK Women's and Children's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Preterm infants 24+0/7 to 32+0/7 weeks who require mask ventilation during resuscitation
- Infants with impaired pulmonary circulation (eg. Cardiac arrest, pulmonary atresia, severe pulmonary stenosis
- Infants with congenital airway anomalies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Monitor Monitor Group 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.
- Primary Outcome Measures
Name Time Method Bradycardia and Desaturation Duration 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 Outcome Measures
Name Time Method Delivery room chest compressions During resuscitation course at birth This outcome will be counted as yes if infant required chest compressions in the delivery room
Delivery room intubation During resuscitation course at birth This outcome will be counted as yes if infant required endotracheal intubation in the delivery room
Delivery room peak inspiratory pressure (PIP) During resuscitation course at birth Peak inspiratory pressure (PIP) used during mask ventilation during resuscitation after birth, measured as cmH20
Delivery room fraction of inspired oxygen level (FiO2) During resuscitation course at birth Fraction of inspired oxygen level (FiO2) measured using an oxygen analyser within the ventilating circuit during mask ventilation (ranges from 0.21-1.0)
Delivery room positive end expiratory pressure (PEEP) During resuscitation course at birth Positive end expiratory pressure (PEEP) used during mask ventilation during resuscitation after birth, measured as cmH20
incidence of severe intraventricular hemorrhage (IVH) During inpatient hospital course, usually 2-3 months ultrasound finding of grade3-4 intraventricular hemorrhage
Apgar Scores During resuscitation course at birth 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
Duration of assisted ventilation before discharge During inpatient hospital course, usually 2-3 months ventilation days on mechanical ventilator or continuous positive airway pressure (CPAP) respectively
incidence of chronic lung disease (CLD) During inpatient hospital course, usually 2-3 months diagnosed when there is a need for oxygen at 36 weeks post menstrual age
Admission blood gas partial pressure of carbon dioxide (pCO2) levels During inpatient hospital course, usually 2-3 months first blood gas pCO2 levels in mmHg
incidence of necrotizing enterocolitis (NEC) During inpatient hospital course, usually 2-3 months diagnosis of NEC proven by abdominal X-rays, classified as Bell Stage II
incidence of severe retinopathy of prematurity (ROP) During inpatient hospital course, usually 2-3 months diagnosed when there is a need for laser surgery for treatment of ROP
Tidal volume during resuscitation During resuscitation course at birth Tidal volume (ml/kg) measured using a respiratory function monitor sensor attached to the mask during mask ventilation
Mask leakage during resuscitation During resuscitation course at birth mask leakage (%) measured and calculated using a respiratory function monitor during mask ventilation
Occurrence of air leak syndromes During inpatient hospital course, usually 2-3 months pneumothorax, pneumomediastinum confirmed on x ray
Trial Locations
- Locations (1)
KK Women's and Children's Hospital
🇸🇬Singapore, Singapore