The Utility of Qualitative End Tidal CO2 Detector in Providing Effective Ventilation During Resuscitation of Preterm Newborns: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Bradycardia and Desaturation Duration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 60 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm infants 24+0/7 to 32+0/7 weeks who require mask ventilation during resuscitation
排除标准
- •Infants with impaired pulmonary circulation (eg. Cardiac arrest, pulmonary atresia, severe pulmonary stenosis
- •Infants with congenital airway anomalies
研究组 & 干预措施
Monitor
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.
干预措施: Monitor Group (Device)
Control
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.
结局指标
主要结局
Bradycardia and Desaturation Duration
时间窗: 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
次要结局
- Delivery room chest compressions(During resuscitation course at birth)
- incidence of severe intraventricular hemorrhage (IVH)(During inpatient hospital course, usually 2-3 months)
- Mask leakage during resuscitation(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)
- 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)
- Occurrence of air leak syndromes(During inpatient hospital course, usually 2-3 months)
研究者
Kong Juin Yee
Consultant Neonatologist
KK Women's and Children's Hospital