Effect of Prone Position on the Use of Non-invasive and Invasive Ventilation in Infants With Moderate to Severe Acute Bronchiolitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 452
- 试验地点
- 16
- 主要终点
- Proportion of ventilated children in each of the 2 groups
研究概览
简要总结
Acute viral bronchiolitis is the leading cause of community-acquired acute respiratory failure in developed countries (20 000 to 30 000 hospitalizations each year in France). Between 5% and 22% of these children are hospitalized in a critical care unit to benefit from a respiratory support.
Non-invasive ventilation, in particular the nasal Continuous Positive Airway Pressure (nCPAP), reduces the work of breathing in children with bronchiolitis and is associated with decreased morbidity and hospitalization costs compared with invasive ventilation. Nowadays, this technique is considered as the gold standard in the pediatric intensive care units (PICU) in France. High Flow Nasal Cannula (HFNC) has been proposed as an alternative to the nCPAP because of its better tolerance and simplicity of implementation. However, the proportion of failure remains high (35 to 50%), providing only a partial response to the care of these children, especially prior to the PICU.
In a physiological study (NCT02602678, article published), it has been demonstrated that prone position (PP) decrease, by almost 50%, the respiratory work of breathing and improve the respiratory mechanics in infants hospitalized in intensive care units for bronchiolitis.
Investigators hypothesize that prone position, during High Flow Nasal Cannula (HFNC), would significantly reduce the use of non-invasive ventilation (nCPAP and others) or invasive ventilation, as compared to supine position during HFNC, in infants with moderate to severe viral bronchiolitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Infant under 6 months
- •Hospitalized in critical care unit (continuous monitoring unit or intensive care unit)
- •With a clinical diagnosis of acute viral bronchiolitis (criterion of the American Academy of Pediatrics 2014)
- •m-WCAS score ≥ 3 and / or hypercapnic acidosis with pH <7.35 and pCO2> 50mmHg (6.7 kPa)
- •Informed consent signed by at least one of the parents with oral consent of the other parent (and / or legal guardian) recorded in the medical file (with deferred written consent).
排除标准
- •Infant admitted with criteria for invasive or non-invasive ventilation (hypercapnic acidosis with pH <7.25 without ventilatory support and/or hypoxia with impossibility of maintaining SpO2> 92% whatever the FiO2 and/or more than 3 significant apneas per hour and/or severe consciousness disorder)
- •Patient already positioned in the prone position before randomization for more than 3 hours
- •Significant comorbidities with a history of respiratory pathology (bronchodysplasia with ventilatory support), Ear Nose and Throat pathology (pharyngolaryngomalacia) or neuromuscular and / or hemodynamically significant congenital heart disease.
- •Contraindication to Prone position : recent abdominal surgery (laparoschisis or omphalocele) or recent sternotomy
- •Patient who is not affiliated (or does not benefit from) to a national social security system
研究组 & 干预措施
Supine position (SP)
Supine position (SP) combined with HFNC
干预措施: Supine position (SP) (Procedure)
Prone position (PP)
Prone position (SP) combined with HFNC
干预措施: Prone position (PP) (Procedure)
结局指标
主要结局
Proportion of ventilated children in each of the 2 groups
时间窗: 3 days
Indications for the use of ventilation (invasive or non-invasive ventilation) will be standardized in both groups (based on the interregional protocol for the management of bronchiolitis): * Clinical aggravation defined by an increase ≥ 1 point of the m-WCAS score * Persistence of hypercapnic acidosis with pH ≤7.30 and pCO2≥ 8 kPa or FiO2\> 60% under HFNC at 2 L/kg/min * More than 3 significant apneas per hour (apnea with desaturation \<90% and / or bradycardia \<90 / min) * Consciousness disorder Anytime over the first 3 days after inclusion
次要结局
- Causes of failure(3 days)
- Length of stay(maximum 3 months)
- Duration of ventilation(maximum 3 months)
- Oxygenation evaluation(24 hours)
- Variation EDIN score (Scale of pain and discomfort of the newborn) between inclusion and after 2 hours(2 hours)
- Proportion of failure(3 days)
- Evaluation of the feasibility of maintaining the position(48 hours)
- Tolerance evaluation(maximum 3 months)
- Oxygenation evaluation(2 hours)
- Oxygenation evaluation(12 hours)