Effectiveness of Chest Physiotherapy in Infants Hospitalized With Acute Bronchiolitis SRV (+): a Randomized Controled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Clinical score of respiratory distress
研究概览
简要总结
The purpose of this research is to determine the effect of prolonged slow expiration techniques, provoked coughing and standard therapy compared to chest wall manual vibration and standard therapy in infants between 0 and 12 months old with confirmed diagnosis of acute bronchiolitis SRV (+). The effect will be measured on respiratory insufficiency and use of supplementary oxygen.
详细描述
Bronchiolitis is the main cause of hospital admission for infants under 1 year old in Chile. Currently, approximately 4800 children are admitted to the hospital during the cold season, affecting the health services' effectiveness. The most frequent causal agent is the Respiratory Syncytial Virus (RSV). To date, there is no specific treatment for this disease and only support measures are recommended.
Chest physiotherapy is a support measure that improves the mucociliary clearance and reduces obstruction of the airways.
A clinical trial on the effect of prolonged slow expiration (PSE), chest wall vibrations, and provoked coughing as treatment for bronchiolitis in infants admitted to the hospital found that the subgroup with RSV required oxygen for 10 hours less than the control group. Gomes and Postiaux (2012) reported a 50% decrease on respiratory distress measured by the Wang score when PSE and suction were compared to traditional chest physiotherapy techniques in patients with bronchiolitis RSV(+).
Currently recommendations in Chile suggest chest physiotherapy for outpatients with bronchiolitis, but the guideline does not refer to the case of inpatients. It is proposed to carry out a randomized controlled trial in infants under one year old. The active group will receive standard therapy, PSE, and provoked coughing, while the control group will receive standard therapy and manual chest wall vibrations. The effectiveness of chest physiotherapy will be measured though a clinical score of respiratory distress, hours using supplementary oxygen, vital signs before and after the intervention in both groups during hospital stay. The main outcome is clinical severity score 48 hours after admission.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Days 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of bronchiolitis.
- •RSV positive in direct immunofluorescence assay.
- •Wang clinical severity score ≥ 4 points.
排除标准
- •Patients with heart or neurological diseases.
- •Previous episodes of wheezing.
- •Chronic conditions such as bronchopulmonary dysplasia, immunodeficiency, or congenital diseases.
- •Need of mechanical ventilation in Intensive Care Unit
- •Contraindication criteria for chest physiotherapy (i.e. Pneumothorax, ribs fractures, hemodynamic instability).
- •Patients not receiving supplementary oxygen.
结局指标
主要结局
Clinical score of respiratory distress
时间窗: 48 hours after baseline measurement
Wang clinical severity score
次要结局
- Peripheral blood oxygen level(Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.)
- Hours of supplementary oxygen(48 hours after baseline measurement)
- General clinical condition(Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.)
- Respiratory rate(Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.)
- Rib cage retractions(Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.)
- Heart rate(Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.)
- wheezing(Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.)
研究者
Patricio Gomolan Gonzalez
Lecturer
Universidad del Desarrollo