Preterm Birth
Conditions
Keywords
end tidal carbon dioxide, mask ventilation, neonatal resuscitation
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.
Interventions
DEVICEMonitor Group
Use of colorimetric end tidal CO2 to guide provider during provision of mask ventilation, where colour change indicates effective breaths
Sponsors
KK Women's and Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 60 Minutes
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 |
| 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) |
| 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 |
| 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 |
| Occurrence of air leak syndromes | During inpatient hospital course, usually 2-3 months | pneumothorax, pneumomediastinum confirmed on x ray |
| 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 severe intraventricular hemorrhage (IVH) | During inpatient hospital course, usually 2-3 months | ultrasound finding of grade3-4 intraventricular hemorrhage |
| 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 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 |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of corrective measures performed | During resuscitation at birth | Number of corrective measures performed to overcome ineffective mask ventilation observed on video recording of resuscitation |
Countries
Singapore
Outcome results
None listed