Efficacy of inspiratory muscle training on maximal inspiratory pressure and dyspnea among post-weaned adult patients at tertiary care center, South India – a randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To assess the efficacy of inspiratory muscle training combined with standard care compared to standard care alone on maximal inspiratory pressure and dyspnea.
研究概览
简要总结
The study will be conducted at JIPMER in the Medical Intensive Care Unit (MICU), Pulmonary Medicine ICU, Medicine Ward, and Ward 27 after obtaining approvals from the Institutional Ethics Committee and the JIPMER Nursing Research Monitoring Committee. Participants who meet the inclusion criteria will be selected using a convenience sampling method, and data collection will take place over a period of a year. A pilot study will be carried out following the necessary approvals. Participants will be enrolled 3 to 5 hours after extubation, and written informed consent will be obtained after providing adequate information using a participant information sheet. Demographic and clinical variables will be collected through a structured subject data sheet. Based on gender, participants will be stratified and randomly allocated into study groups.
Baseline maximal inspiratory pressure (MIP) will be assessed by instructing participants to exhale fully and then perform a forced inhalation through a respiratory muscle training device. MIP will be recorded for five consecutive days. The severity of dyspnea will be measured using the Respiratory Distress Observation Scale (RDOS), which includes monitoring heart rate, respiratory rate, breathing patterns (paradoxical breathing, use of accessory muscles, grunting, nasal flaring), and facial expressions (restlessness, look of fear). RDOS will be assessed at baseline and again after completing 10 intervention sessions.
The intervention involves a breathing exercise where participants exhale completely, inhale through the device, and then exhale slowly using pursed-lip breathing. Each session will include five sets of six breaths (a total of 30 breaths per session), provided twice daily for five days, totaling 10 sessions. A trained person will record the MIP after each day’s second session, and RDOS will be reassessed after the final session. Participants will be followed until discharge, and the length of hospital stay will be documented. The total duration required for each participant in the intervention group is approximately six minutes per day and 32 minutes over five days. In contrast, the standard care group will require only one minute per session, totaling 12 minutes over five days.
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研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
入选标准
- •Patients weaned from the mechanical ventilator who were on mechanical ventilation for at least 7 days Aged more than 18 years and both Gender GCS more than 13 After 3-5 hours of extubation, volitional MIP of -20 to -80 cms of water for 2 seconds.
排除标准
- •Hemodynamically unstable Acute cerebrovascular accident Acute delirium Spontaneous pneumothorax Rib fracture Cervical spine fracture Pregnancy Recent abdominal surgery Tracheostomised patients.
结局指标
主要结局
To assess the efficacy of inspiratory muscle training combined with standard care compared to standard care alone on maximal inspiratory pressure and dyspnea.
时间窗: 1. MIP | 6 time points | Baseline, Post-Intervention (Evening) from Day 1 to Day 5 | 2. Dyspnea | 2 time point | Baseline and Postintervention (Day 5)
次要结局
- • To compare the re-intubation incidence ratio between the intervention and standard care groups.(• To compare the severity of illness and length of stay after extubation between the intervention and standard care groups.)
研究者
Jeyaveeranan N
Jawaharlal Institute of Postgraduate Medical Education and Research