Bubble Continuous Positive Airway Pressure Oxygen Therapy (Biodesign Innovation Labs’s RESPAP KIT )in Children under Five Years of Age with Pneumonia in Pediatric Intensive Care Unit (PICU)-A Pilot study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The need for invasive ventilation (primary outcomes) 

研究概览
简要总结
This Prospective Observational Study study will be performed at St John’s medical college hospital, an urban tertiary referral hospital with 12-bedded PICU. The children from 5 months of age to 58 months of age meeting the inclusion criteria will be enrolled in the PICU. Children with mild to moderate respiratory distress score will be started on B-CPAP. The severity of respiratory distress will be determined using following variables, (respiratory rate, air entry, retractions, grunt, saturation in room air and level of consciousness). These variables will be recorded and graded according to modified Wood-Downes score. The highest scores from each variable were summed to attain the total severity score and graded as :1- 3, mild; 4-7, moderate; 8-12, severe. (19)
Aims and Objective(s) of the Study
This study is planned to look at its effectiveness of B-CPAP in reducing the need for invasive ventilation and its safety as a form of respiratory support in children with pneumonia.
Primary objective:
1)To determine the efficacy and safety of Biodesign Innovation Labs’ Respap kit , a B-CPAP based oxygen therapy for children under 5 years with mild to moderate respiratory distress due to Pneumonia
Secondary Objective:
- To assess the complications during use of B-CPAP and perception of ‘ease of use’ by nursing staff 

研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 5.00 Month(s) 至 60.00 Month(s)（—）
- 性别
- All
入选标准
- •Children aged 5-59 months with diagnosis of pneumonia with mild to moderate respiratory distress.
排除标准
- •Those patients who required immediate intubation (<1hour), 2) low level of consciousness (GCS<10) 3)less than 24 hours of stay in PICU, 4) absent cough/ gag reflex, 5) hemodynamic instability 6)recent facial, upper airway or upper gastrointestinal tract surgery, 7)undrained pneumothorax 8)Hypercapnia (PCO2 > 60 mm of Hg),.
结局指标
主要结局
The need for invasive ventilation (primary outcomes) 

时间窗: 1st time point:6 hours | 2nd time point:24 hrs
2.Complications during use and perception of ‘ease of use’ by nursing staff (secondary outcomes)
时间窗: 1st time point:6 hours | 2nd time point:24 hrs
次要结局
- Length of hospital stay ,duration of respiratory support(28 days)