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Clinical Trials/NCT04021615
NCT04021615
Completed
N/A

Comprehensive Rehabilitation Program Versus Traditional Chest Physiotherapy for Weaning From Mechanical Ventilator

Sherin Hassan Mohammed Mehani1 site in 1 country50 target enrollmentJuly 21, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mechanical Ventilation Complication
Sponsor
Sherin Hassan Mohammed Mehani
Enrollment
50
Locations
1
Primary Endpoint
percentage of successful weaning in both groups
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 21, 2019
End Date
January 10, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sherin Hassan Mohammed Mehani
Responsible Party
Sponsor Investigator
Principal Investigator

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

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

Outcomes

Primary Outcomes

percentage of successful weaning in both groups

Time Frame: 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)

Time Frame: 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

Secondary Outcomes

  • 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)

Study Sites (1)

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