Comparison Between Continuous Positive Airway Pressure (CPAP) and Non Invasive Positive Pressure Ventilation (NiPPV) in Bronchiolitis Under Non- Invasive Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Esophageal pressure-time product per minute (PTPes/min)
研究概览
简要总结
Severe acute viral bronchiolitis is the leading cause of pediatric intensive care admission. The first-line recommended ventilation support is continuous positive airway pressure (CPAP), which reduces the work of breathing (WOB) and improves gas exchange. Although Non invasive Positive Pressure Ventilation (NiPPV) is increasingly used in case of CPAP failure to avoid intubation, no study has yet evaluated if this support could effectively reduce the effort of breathing.
Our hypothesis is that NiPPV could reduce WOB more effectively than CPAP alone, and might lead to reduce intubation in the most severe bronchiolitis.
The purpose of this study is to compare WOB between CPAP and NiPPV, thanks to esophageal pressure measurement, in infants hospitalized for severe acute bronchiolitis.
详细描述
Severe acute viral bronchiolitis is the leading cause of pediatric intensive care admission. The first-line recommended ventilation support is non invasive ventilation (NIV) with continuous positive airway pressure (CPAP), which has been proved to reduce the work of breathing (WOB) and improve gas exchange. Non invasive Positive Pressure Ventilation (NiPPV) is increasingly used in case of CPAP failure to avoid intubation. Nevertheless, no study has ever evaluated its effectiveness on the discharge of respiratory muscles in severe bronchiolitis.
Measurement of esophageal and gastric pressures with an esogastric catheter allows an estimation of WOB thanks to the calculation of the esophageal pressure-time product (PTPes), and a calculation of the transdiaphragmatic pressure (Pdi) as the difference between gastric and esophageal pressures. This minimally invasive technique can be used at the bedside to assess the efficacy of ventilation support and is now increasingly used in Intensive Care Units to assist ventilation-targeted strategies.
Our hypothesis is that NiPPV could reduce WOB more effectively than CPAP alone, and might lead to reduce intubation in the most severe bronchiolitis.
The main purpose of this study is to compare PTPes/min between CPAP and NiPPV in infants hospitalized for severe acute bronchiolitis.
Secondary objectives are i) to compare other parameters of WOB, gas exchanges and breathing pattern in both ventilator supports ii) to compare the rate of patient-ventilator asynchronies in 2 different setting of NiPPV ("clinical" and "physiological") iii) to assess if NiPPV is associated with reduced intubation rate, time under sedation and ventilation, and length of hospitalization as compared to CPAP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and radiological diagnosis of bronchiolitis
- •Need for non-invasive ventilation support (NiPPV or CPAP) with a modified Wood clinical asthma score (m-WCAS)> 4 and / or hypercapnic acidosis (pH <7.3 and / or pCO2> 50mmHg)
- •Written parental informed consent
排除标准
- •Contraindication to nasogastric tube (recent surgery of the esophagus, esophageal malformation at risk of perforation, severe coagulopathy)
- •Absolute or relative contraindication to NIV
- •Respiratory collapse: coma (GCS <12) and / or more than 3 apneas per hour with bradycardia <90 / min and / or SpO2 <90%
- •Pneumothorax
- •Preexisting disorder that may influence WOB
- •Neuromuscular disease
- •Chronic respiratory failure already under NIV or tracheostomy at home
- •No social security
研究组 & 干预措施
Severe acute bronchiolitis
Infants under 6 months admitted in Pediatric Intensive Care Unit for a severe acute bronchiolitis needing NIV (modified Woof clinical asthma score (WCAS) >4 and/or hypercapnic acidosis (pH<7,3 and/or pCO2>50mmHg)
干预措施: Esogastric pressures measurement (Other)
结局指标
主要结局
Esophageal pressure-time product per minute (PTPes/min)
时间窗: 20 minutes
Esophageal pressure-time product per minute (PTPes/min) is calculated by the area under the curve of the Pes during inspiration, expressed in cmH2O.s / min. The PTPes/min will be measured under CPAP (" clinical" and "physiological" setting) and under NiPPV (" clinical" and "physiological" setting) during a period of quiet breathing of 5 minutes.
次要结局
- Total respiratory cycle time (Ttot)(20 minutes)
- Tidal volume (Vt)(20 minutes)
- Respiratory rate (RR)(20 minutes)
- Inspiratory time (Ti)(20 minutes)
- Gas exchange(3 hours)
- Number of days under sedation by Midazolam IV or per os upon hospital discharge(Through study completion, an average of 2 years)
- Heart rate (HR)(20 minutes)
- PEdiatric Logistic Organ Dysfunction-2 score (PELOD-2)(At inclusion and at the end of the measurements, i.e. 3 hours from inclusion)
- Modified Wood's Clinical Asthma Score (m-WCAS)(At inclusion and at the end of the measurements, i.e. 3 hours from inclusion)
- Work of breathing(20 minutes)
- Need for intubation(Through study completion, an average of 2 years)
- Number of days under NIV(Through study completion, an average of 2 years)
- Number of days under invasive ventilation(Through study completion, an average of 2 years)
- Number of days in intensive care unit(Through study completion, an average of 2 years)
- Number of days in hospitalization(Through study completion, an average of 2 years)
- Patient-ventilator asynchronies (under NiPPV)(Through study completion, an average of 2 years)