Comprehensive Rehabilitation Program Versus Traditional Chest Physiotherapy for Weaning From Mechanical Ventilator
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- percentage of successful weaning in both groups
研究概览
简要总结
Statement of the problem:
Are there any differences between comprehensive rehabilitation program consisted of (peripheral muscle training and functional training) combined with inspiratory muscle training and traditional chest physical therapy consisted of (percussion, mechanical vibration, positioning and modified postural drainage) combined with inspiratory muscle training on weaning from mechanical ventilation as a primary outcome, respiratory muscle strength, peripheral muscle strength and functional status in difficult and prolonged weaning from mechanical ventilation as secondary outcomes?
Purpose of the study:
The aim of the present study will be to compare between the effect of comprehensive rehabilitation program combined with inspiratory muscle training and traditional chest physical therapy combined with inspiratory muscle training on weaning from mechanical ventilation as a primary outcome, inspiratory muscle strength, peripheral muscle strength, functional status as secondary outcomes.
详细描述
Significance of the study Survival of critically ill patients has increased as a result of medical technology and interdisciplinary team cooperation.
Functional losses , reduced quality of life and survival , and increased healthcare costs are consequences of prolonged immobility in ICU.
The European Respiratory Society and European Society of Intensive Care Medicine task force has recommended a hierarchy of ICU mobilization based on progressively increasing exercise intensity; decubitus change and functional positioning , passive mobilization , active- assisted and active exertion , cycloegonometry in bed , sitting in bed orthostatism , static walking , transferring from bed to chair, chair exertion and walking.
Failure to wean may have different etiologies such as underlying severe respiratory disease, respiratory muscle dysfunction , metabolic and endocrine disorders and cognitive dysfunction. Peripheral and respiratory muscles dysfunction is a consequence of prolonged mechanical ventilation and ICU- acquired weakness. Weaning from mechanical ventilator should be considered to be as early as possible to avoid complications caused by absence of spontaneous breathing and further muscles atrophy.
Targeted mobility therapy (TMT) , simulating comprehensive rehabilitation program that will be used in the present study, is a novel strategy for managing critically ill patients . This concept will work as a scientifically- driven, dynamic bundle of rehabilitation intervention that include inspiratory muscle strength training , bronchial hygiene , and active mobilization . This concept will guarantee the bet outcomes for critically ill patients with difficult and prolonged weaning as regards weaning success , days on mechanical ventilator , length of hospital stay and functional mobility.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The general surgery patients who fail one weaning attempt of spontaneous breathing trial
- •Conscious patients
- •Hemodynamically stable patients (lack of hypotension or a need for only low-dose pressors)
- •The patients with Acute Physiology and Chronic Health Evaluation II (APACHE II) scale 20 or less
排除标准
- •patients with persistent altered sensorium
- •patients with major cardiac arrhythmia
- •patients with comorbid medical conditions (e.g., neurological diseases) or who are under any sedative or paralytic agents that would interfere with strength measurements and limb exercises
- •patients with history of underlying neuromuscular disease or acquired polyneuromyopathies
- •patients who are unable to perform physical training due to preexisting joint dysfunction
- •obese patients
研究组 & 干预措施
Group A (study group)
Forty-five patients will receive a comprehensive rehabilitation programme combined with inspiratory muscle training.
干预措施: Comprehensive physical therapy rehabilitation program combined with inspiratory muscle training (Other)
Group B (Control group)
Forty-five patients will receive traditional chest physical therapy combined with inspiratory muscle training.
干预措施: Traditional chest physical therapy rehabilitation program combined with inspiratory muscle training (Other)
结局指标
主要结局
percentage of successful weaning in both groups
时间窗: 30 days maximum or until extubation
Spontaneous breathing trials will be used when underlying cause of acute respiratory failure stabilizes or significantly improves and daily assessment of the patient's readiness for ventilator discontinuation is considered. The spontaneous breathing trial will last from 30 minutes to 120 minutes combined with CPAP and if the trial had failed, the patient will be returned back to full ventilatory support for at least 24 hours before performing a new trial Weaning success is defined as extubation and the absence of ventilatory support 48 hous following extubation
inspiratory muscle strength (MIP)
时间窗: 30 days maximum or until extubation
The mechanical ventilator will be used to measure the plateau pressure (maximal inspiratory pressure). Plateau pressure was measured using the inspiratory hold function on the venilator while the patient will be sedated and on volume control mode (Sidebotham et al., 2007) The plateau pressure will be measured by ventilator in millibar then it converted to cm o by multiplying it by 1.01971621298 (1millibar equals 1.01971621298 cm 0) and near the figure to the nearest two decimal places
inspiratory muscle strength (MIP)
时间窗: at baseline and at immediately before the spontaneous breathing trial
The mechanical ventilator will be used to measure the plateau pressure (maximal inspiratory pressure). Plateau pressure was measured using the inspiratory hold function on the venilator while the patient will be sedated and on volume control mode (Sidebotham et al., 2007) The plateau pressure will be measured by ventilator in millibar then it converted to cm o by multiplying it by 1.01971621298 (1millibar equals 1.01971621298 cm 0) and near the figure to the nearest two decimal places
次要结局
- The Functional Independence Measure (FIM)(30 days maximum or until extubation)
- Upper and lower extremity muscle strength(30 days maximum or until extubation from mechanical ventilator successfully)
- Upper and lower extremity muscle strength(at baseline and at 30 days maximum or until extubation from mechanical ventilator successfully)
- The Functional Independence Measure (FIM)(at baseline and at 30 days maximum or until extubation from mechanical ventilator successfully)
- Rapid shallow breathing index (RSBI)(at baseline and immediately before the spontaneous breathing trial)
- Pain level(at baseline and at 30 days maximum or until extubation from mechanical ventilator successfully)
- days to wean(at baseline and at 30 days maximum or until extubation from mechanical ventilator successfully)
研究者
Sherin Hassan Mohammed Mehani
Chairman of Physical Therapy Department of Internal Medicine and Vic Dean for Education and Student Affairs , Faculty of Physical Therapy , Beni- Suef University
Beni-Suef University