Impact of Increasing Flow Rates in High-flow Nasal Cannula and CPAP on Diaphragmatic Work in Newborn and Paediatric Population: Non-inferiority Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Variations of mean max electrical activity of the diaphragm (mean EAdi) between different HFNC flows and between each HFNC flow and CPAP
研究概览
简要总结
The goal of this randomised controlled, cross-over clinical trial is to compare High Flow Nasal Cannulas (HFNC) and Continuous Positive Airways Pressure (CPAP) in neonates over 34 weeks' amenorrhoea (SA) up to children weighing less than 20 kg with respiratory failure.
The main question it aims to answer is the non-inferiority of high flows of high-flow nasal cannula compared with CPAP by analysis of diaphragmatic contraction (EAdi (Electrical activity of diaphragm)).
Participants with respiratory failure and need of non invasive ventilation and nasogastric tube will receive 4 different increasing flows of HFNC and Positive End-Expiratory Pressure of 7 cmH2O with CPAP during 30 minutes for each flow rate and CPAP. The electrical activity of diaphragm and clinical data of the patient upon each flow and support will be collected. According to the cross-over procedure, the patients will change groups (increasing flows of HFNC or CPAP) in order to perform the remaining analysis.
详细描述
With this research protocol, the investigators aim to demonstrate the non-inferiority of high flows of HFNC compared with CPAP on work of breathing (based on the intensity of contraction of diaphragmatic fibres and clinical aspects) in paediatric and neonatal patients. The investigators will also study the clinical tolerance and safety of these practices.
Objectives :
Main objective: To demonstrate the non-inferiority of high-flow nasal cannula flow rates compared with CPAP by analysis of diaphragmatic contraction (EAdi (Electrical activity of diaphragm)) in neonates over 34 weeks' amenorrhoea (SA) up to children weighing less than 20 kg in respiratory failure.
Secondary objectives:
- To compare different flows of HFNC (2 L/kg/min, 3 L/kg/min, 4 L/kg/min, 5 L/kg/min) with each other by analysing diaphragmatic contraction.
- Compare the clinical effectiveness of different flow rates of HFNC with CPAP in young children in respiratory distress.
- To compare the tolerability of different flow rates of HFNC with CPAP in the population of young children suffering from respiratory distress.
- To compare the incidence of minor (digestive discomfort, digestive bloating, non-damaging skin lesions) and major (thoracic barotrauma, damaging skin lesions) side effects of different flow rates of HFNC with CPAP in young children in respiratory distress.
- To describe the choice of support and settings (flow rates or PEEP levels) made by the practitioners in charge of the child after the study period.
- To describe the epidemiological data from the paediatric intensive care and monitoring units and the neonatal intensive care unit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 34 Weeks 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns over 34 SA and paediatric patients weighing less than 20 kg.
- •Need for ventilatory support by HFNC or CPAP for respiratory failure
- •Need for enteral feeding via nasogastric tube
- •Hospitalized in PICU or NICU at Clermont-Ferrand University Hospital,
- •Covered by Social Security.
- •Whose parents or guardians are able to provide informed consent to participate in the research.
排除标准
- •Respiratory failure requiring immediate intubation.
- •Use of HFNC or CPAP as a relay to extubation.
- •Acquired or congenital abnormality of the gastrointestinal tract.
- •Diaphragmatic paralysis and/or neuromuscular pathology
- •Failure of central ventilatory control (e.g. intra-ventricular haemorrhage, anoxic-ischaemic encephalopathy, massive vascular accident, intracranial process, cerebral edema and/or intracranial hypertension).
- •Contraindications listed in the CPAP and HFNC user manuals: absence of spontaneous ventilation, choanal atresia, diaphragmatic hernia, tracheo-oesophageal fistula, nasal trauma, severe deformity likely to be aggravated by the nasal mask or nasal cannula, pneumothorax, pneumencephaly, Cerebrospinal Fluid leak, hypotension.
- •Refusal by parents or guardians.
结局指标
主要结局
Variations of mean max electrical activity of the diaphragm (mean EAdi) between different HFNC flows and between each HFNC flow and CPAP
时间窗: Maximal electrical activity of diaphragm will be recorded every minutes (up to 3 hours)
Maximal EAdi will be measured in µV
次要结局
- Variations of respiratory distress score between the different rates of HFNC and between each rate of HFNC and CPAP(Every 30 minutes during 3 hours)
- Variation in mean minimum EAdi (EAdi min) between different HFNC flows and between each HFNC flow and CPAP(Minimal electrical activity of diaphragm will be recorded every minutes (up to 3 hours))
- Variations of respiratory rate between the different rates of HFNC and between each rate of HFNC and CPAP(every 5 minutes during 3 hours)
- Variations of heart rate between the different rates of HFNC and between each rate of HFNC and CPAP(every 5 minutes during 3 hours)
- Ventilatory weaning time(From date of randomization until the date of pressure weaning support, up to 30 days.)
- Variations of oxygen saturation between the different rates of HFNC and between each rate of HFNC and CPAP(every 5 minutes during 3 hours)
- Variations of transcutaneous partial pressure of carbon dioxide between the different rates of HFNC and between each rate of HFNC and CPAP(every 5 minutes during 3 hours)
- Incidence of minor side effects for each HFNC flow rate and for CPAP(Every 30 minutes during 3 hours)
- Incidence of major side effects for each flow of HFNC and for CPAP(Every 30 minutes during 3 hours)
- Intubation rate(through patient follow-up period, up to 3 hours)