Effect Of Inspiratory Muscle Training and Early Mobilization to Improve Oxygenation and Pulmonary Functions in Patients with Pediatric Cardiac Surgery: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Oxygenation
研究概览
简要总结
Male or female participants age 4-14 years are included in the study based on specific eligibility criteria. Informed written and verbal consent will be obtained from the parents of the participants before data collection. Demographic information including name age gender relevant medical and surgical history will be documented. All outcome variables will be measured on the first day before intervention, and on 6th day of surgery participants will be randomly allocated into 2 groups using block randomization: the interventional group will receive inspiratory muscle training with early mobilisation , while the control group will receive usual physiotherapeutic care. The outcome measure will include Oxygenation, Pulmonary functions, ABG Analysis, Heart rate, respiratory rate, Pain and the final conclusion will be drawn based on the comparative effectiveness of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 14.00 Year(s)(—)
- 性别
- All
入选标准
- •Both Male and female
- •Age 4-14 years
- •Both Invasive and Non-Invasive cardiac surgery procedures.
排除标准
- •Unstable patients
- •Patients with any neurological defect (eg- spina bifida,cerebral palsy)
- •Patients on mechanical ventilation support.
结局指标
主要结局
1. Oxygenation
时间窗: At baseline and on the 6th day of the surgery
2. Pulmonary Functions-Pimax
时间窗: At baseline and on the 6th day of the surgery
3. ABG Analysis-pH.PCO2
时间窗: At baseline and on the 6th day of the surgery
次要结局
- 1. Heart Rate(2. respiratory Rate)
研究者
Dr Sanika Girish Khawase
MGM Institute of Physiotherapy
