Diaphragmatic Activity During Constant or Variable Flow CPAP in Neonates: a Non-inferiority, Randomized, Alternating Treatments Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean swing EAdi (µV)
研究概览
简要总结
The hypothesis behind the study is that the performance of constant flow CPAP (Continuous Positive Airway Pressure) devices (CF-CPAP) is not inferior to that of variable flow CPAP devices (VF-CPAP) in terms of respiratory efforts assessed by swing EAdi (Electrical activity of diaphragm) in a population of premature neonates born ≤ 32 weeks of gestational age.
详细描述
CPAP is an indispensable tool in NICU (neonatal intensive care unit ) to recruit and maintain lung volume, to reduce airway resistances and increase pulmonary compliance. However, the variety of existing pressure generators (constant-flow=CF-CPAP or variable flow=VF-CPAP) and interfaces (prongs, masks) makes evidence-based clinical decisions difficult. Considering the persisting controversy regarding the comparative efficacy of CF-CPAP versus VF-CPAP, new less- or non-invasive tools such diaphragmatic electrical activity (EAdi) monitoring may allow to better evaluate their impact on respiratory efforts.
Our hypothesis is that CF-CPAP devices with nasal mask are not inferior to VF-CPAP devices with nasal mask regarding respiratory efforts assessed by observed swing EAdi in a population of neonates born at ≤ 32 weeks gestational age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 72 Hours 至 10 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •apply to gestational age at birth and postmenstrual age (in weeks).
- •Inclusion Criteria:
- •Neonates born at ≤ 32 weeks GA (gestational age)
- •Hospitalized in our tertiary hospital NICU (Neonatal intensive care unit)
- •Receiving CPAP since > 24 hours at inclusion
- •Equipped with EAdi catheters.
- •Aged more than 72 hours
- •With parental consent
- •Affiliated to or benefiting from a social security system
- •Non inclusion Criteria:
- •More than 1 episode of apnea / hour and/or hypercapnic acidosis (defined as pH < 7.20 and/or pCO2 > 65)
- •FiO2 > 60%
- •Neonatal ARDS (acute respiratory distress syndrome) according to the Montreux definition
- •Pneumothorax/ pneumomediastinum
- •Nasal lesions contraindicating nasal noninvasive ventilation
- •Major congenital malformation/Chromosomopathies
- •Congenital neuromuscular diseases
- •Hemodynamic instability
排除标准
- 未提供
研究组 & 干预措施
BBAA (VF-CPAP; VF-CPAP;CF-CPAP;CF-CPAP)
干预措施: VF-CPAP; VF-CPAP; CF-CPAP; CF-CPAP (Device)
AABB (CF-CPAP; CF-CPAP;VF-CPAP;VF-CPAP)
干预措施: CF-CPAP; CF-CPAP; VF-CPAP; VF-CPAP (Device)
ABBA (CF-CPAP; VF-CPAP;VF-CPAP;CF-CPAP)
干预措施: CF-CPAP; VF-CPAP; VF-CPAP; CF-CPAP (Device)
BAAB (VF-CPAP; CF-CPAP;CF-CPAP;VF-CPAP)
干预措施: VF-CPAP; CF-CPAP; CF-CPAP; VF-CPAP (Device)
结局指标
主要结局
Mean swing EAdi (µV)
时间窗: Continuous recording during 1 hour and 30 minutes after a 30 minutes wash-out period for each ventilation period
EAdi will be recorded during each ventilation period with CF-CPAP or VF-CPAP and the mean swing EAdi will be calculated after a 30 minutes wash-out period for each ventilation period
次要结局
- COMFORTneo score(At the beginning and at the end of each ventilation period, up to 2 hours)
- Transcutaneous CO2 pressure TcPCO2 (mm Hg)(Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation period)
- Heart rate beats per minute (bpm)(Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation)
- Number of events of Bradycardia < 100 bpm(During each ventilation period, up to 2 hours)
- Respiratory rate cycles/minute(Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation)
- SPO2 (%)(Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation)
- Mean arterial blood pressure (mm Hg)(At the beginning and at the end of each ventilation period, up to 2 hours)
- Mean phasic peak EAdi (µV)(Continuous recording during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation period])
- Mean tonic peak EAdi (µV)(Continuous recording during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation period)
- CPAP level (cm H20)(Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation)
- CPAP flow if variable flow CPAP (l/min)(Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation)
- FiO2 (%)(Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation)
- Number of events of Desaturation < 80 %(During each ventilation period, up to 2 hours)
- Number of adverse events(During each ventilation period, up to 2 hours)