High Flow Therapy vs Hypertonic Saline in Bronchiolitis Treatment. Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Difference in mean Respiratory Assessment Change Score (RACS) between groups in every time considered
研究概览
简要总结
The purpose of this study is to demonstrate that heated, humidified, high-flow nasal cannula (HHHFNC) is superior to hypertonic saline solution (HSS) in the treatment of moderate acute viral bronchiolitis in infants in improving respiratory distress and comfort and reducing length of hospital stay (LOS) and admission to Pediatric Intensive Care Unit (PICU).
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 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6 months or less
- •Moderate (Respiratory Distress Assessment Instrument score of 4 or greater) viral bronchiolitis (as defined by McConnockie)
- •Meeting Admission criteria
排除标准
- •History of prematurity
- •Chronic lung disease
- •Cystic fibrosis
- •Congenital heart disease
- •Neuromuscular disease
- •Airway anomalies
- •Immunodeficiency
- •Those requiring immediate intubation and ventilation.
研究组 & 干预措施
HSS (3%) + epinephrine
Nebulized solution containing 0.5 mL/kg (maximum 3 mL) of epinephrine 1/1000 plus 2 mL of HSS(3%) every 4h for three times and afterwards at physician in charge criteria.
干预措施: Epinephrine 1/1000 (Drug)
HSS (3%) + epinephrine
Nebulized solution containing 0.5 mL/kg (maximum 3 mL) of epinephrine 1/1000 plus 2 mL of HSS(3%) every 4h for three times and afterwards at physician in charge criteria.
干预措施: HSS 3% (Drug)
HHHFNC+epinephrine+Normal Saline(0.9%)
Flow depending on weight (Tidal volume x respiratory rate x 9) and nebulized solution containing 0.5 mL/kg (maximum 3 mL) of epinephrine 1/1000 plus 2 mL of Normal Saline (NS) (0.9%) every 4h and afterwards at physician in charge criteria.
干预措施: Epinephrine 1/1000 (Drug)
HHHFNC+epinephrine+Normal Saline(0.9%)
Flow depending on weight (Tidal volume x respiratory rate x 9) and nebulized solution containing 0.5 mL/kg (maximum 3 mL) of epinephrine 1/1000 plus 2 mL of Normal Saline (NS) (0.9%) every 4h and afterwards at physician in charge criteria.
干预措施: HHHFNC (Device)
HHHFNC+epinephrine+Normal Saline(0.9%)
Flow depending on weight (Tidal volume x respiratory rate x 9) and nebulized solution containing 0.5 mL/kg (maximum 3 mL) of epinephrine 1/1000 plus 2 mL of Normal Saline (NS) (0.9%) every 4h and afterwards at physician in charge criteria.
干预措施: NS (0.9%) (Drug)
结局指标
主要结局
Difference in mean Respiratory Assessment Change Score (RACS) between groups in every time considered
时间窗: Every 4h for three consecutive times beginning in the moment of inclusion in the study and after every 8h for three consecutive times (average of 36h)
RACS is calculated by combining 2 values: the difference between the Respiratory Distress Assessment Instrument (RDAI) score before and after treatment, plus a value of +1 for each 10% improvement (decrease) in the posttreatment respiratory rate (RR) or a value of -1 for each 10% worsening (increase) in RR.
次要结局
- Difference in mean comfort score along the monitoring period between groups(Every 8h for 6 consecutive times (two days) beginning in the moment of inclusion in the study)
研究者
MªMercedes Bueno Campaña
Dr
Ministry of Health, Spain