Effect of the Tailor-Made Water Column Pressure Base Inspiratory Muscle Trainer (TMWCP-IMT) on Inspiratory Muscle Strength and to reduce postoperative pulmonary complications in patients undergoing Upper Abdominal Surgery - A Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1.Vital Parameters
研究概览
简要总结
This study aims to study the effect of the Tailor-Made Water Column Pressure Base Inspiratory Muscle Trainer (TMWCP-IMTon inspiratory muscle strength and to reduce postoperative pulmonarycomplications in patients undergoing Upper Abdominal Surgery. 30 patients will be recruited based on the inclusion and exclusion criteria of the study. After the recruitment, a verbal and written informed consent form will be obtained. All the basic demographic information will be documented, following outcome measures like Maximal Inspiratory Pressure & Pulmonary Function Test will be taken at baseline of i.e. on 2nd day and at the end of the protocol i.e. 7th day. Data will be collected & will be statistically analyzed and results will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participants are willing to participate.
- •2.Patients with elective upper abdominal surgery.
- •3.Both male and female 4.Patient with stable hemodynamics 5.American Association of Anesthesiology (ASA) Grade 1 &
- •Grade 1 -A normal healthy patient (non- smoking or minimal alcohol) Grade 2 – A patient with mild systemic diseases (without functional limitations).
排除标准
- •1.Subject with pre diagnosed respiratory pathology.
- •2.Subject who has a history of smoking.
- •3.Subject already diagnosed with any neuromuscular disease which directly affects the lung functions.
- •Subject on drugs which will suppress or affect the outcome measures, e.g. bronchodilators.
结局指标
主要结局
1.Vital Parameters
时间窗: 1 times on the day of recruitment and on the 7th day
2.Maximum Inspiratory Pressure (Inspiratory muscle strength)
时间窗: 1 times on the day of recruitment and on the 7th day
次要结局
- PFT lung function – (FEV1, FVC, FEV1/FVC & PEFR).(1 times on the day of recruitment and on 7th day)
研究者
Dr Hritika Pratap Malve
DVVPFs College of Physiotherapy