Clinical trial NCT04021615: Rehabilitation Program for Weaning From Mechanical Ventilator
Official title: Comprehensive Rehabilitation Program Versus Traditional Chest Physiotherapy for Weaning From Mechanical Ventilator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation Complication
Keywords: rehabilitation
general surgery
difficult weaning
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Fifty general surgery patients who are difficult and prolonged weaning patients from both sexes (men \& women) with age ranged from 40 to 50 years old in surgical intensive care unit, Kasr Al Ainy Teaching Hospital, Cairo University and Beni- Suef Teaching Hospital , Beni -Suef University.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: percentage of successful weaning in both groups
timeFrame: 30 days maximum or until extubation
measure: inspiratory muscle strength (MIP)
timeFrame: 30 days maximum or until extubation
Secondary outcomes:
measure: Upper and lower extremity muscle strength
timeFrame: 30 days maximum or until extubation from mechanical ventilator successfully
measure: The Functional Independence Measure (FIM)
timeFrame: 30 days maximum or until extubation
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: surgical intensive care unit, Kasr Al Ainy Teaching Hospital, Cairo University and Beni- Suef Teaching Hospital , Beni -Suef University.
Study officials:
affiliation: Faculty of Medicine , Beni -Suef University
name: Hatem ELMoutaz, Professor
role: STUDY_DIRECTOR
References:
citation: Nava S, Fasano L. Inspiratory muscle training in difficult to wean patients: work it harder, make it better, do it faster, makes us stronger. Crit Care. 2011;15(2):153. doi: 10.1186/cc10125. Epub 2011 Apr 18.