Rehabilitation Program for Weaning From Mechanical Ventilator

NCT ID: NCT04021615

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-21
• Study Completion Date: 2020-01-10

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.

Conditions

Mechanical Ventilation Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A (study group)

Twenty five patients will receive comprehensive rehabilitation program combined with inspiratory muscle training.

Group Type: EXPERIMENTAL

Comprehensive physical therapy rehabilitation program combined with inspiratory muscle training

Intervention Type: OTHER

A threshold inspiratory muscle trainer will be connected to the artificial airway with 15 mm and 22 mm adaptors. Training bouts consist of three to five sets of six repetitions breathing through the trainer. Training will be conducted with the patient in bed with an approximately 30° head-up tilt and with intensity about 40 %- 50 % of maximal inspiratory pressure. Patients will be returned to mechanical ventilation for rest between training sets as needed. Three to five sets of six training breaths will be completed for a total of 18 to 30 training breaths per session. Following each training set, the patient indicated a rating of perceived inspiratory exertion on modified Borg scale . The study group will also receive comprehensive rehabilitation program consist of upper-extremity exercises, lower extremity exercises, pedaling exercises, trunk control exercises and bedside functional training

Group B (Control group)

Twenty five patients will receive traditional chest physical therapy combined with inspiratory muscle training.

Group Type: ACTIVE_COMPARATOR

Traditional chest physical therapy rehabilitation program combined with inspiratory muscle training

Intervention Type: OTHER

The same inspiratory muscle training for the study group combined with the traditional physical therapy program consist of positioning , modified postural drainage , percussion , vibration.

Interventions

Comprehensive physical therapy rehabilitation program combined with inspiratory muscle training

A threshold inspiratory muscle trainer will be connected to the artificial airway with 15 mm and 22 mm adaptors. Training bouts consist of three to five sets of six repetitions breathing through the trainer. Training will be conducted with the patient in bed with an approximately 30° head-up tilt and with intensity about 40 %- 50 % of maximal inspiratory pressure. Patients will be returned to mechanical ventilation for rest between training sets as needed. Three to five sets of six training breaths will be completed for a total of 18 to 30 training breaths per session. Following each training set, the patient indicated a rating of perceived inspiratory exertion on modified Borg scale . The study group will also receive comprehensive rehabilitation program consist of upper-extremity exercises, lower extremity exercises, pedaling exercises, trunk control exercises and bedside functional training

Intervention Type: OTHER

Traditional chest physical therapy rehabilitation program combined with inspiratory muscle training

The same inspiratory muscle training for the study group combined with the traditional physical therapy program consist of positioning , modified postural drainage , percussion , vibration.

Intervention Type: OTHER

Other Intervention Names

Comprehensive physical therapy rehabilitation program; Traditional physical therapy rehabilitation program

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sherin Hassan Mohammed Mehani

OTHER

Sponsor Role: lead

Responsible Party

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

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hatem ELMoutaz, Professor

Role: STUDY_DIRECTOR

Faculty of Medicine , Beni -Suef University

Locations

surgical intensive care unit, Kasr Al Ainy Teaching Hospital, Cairo University and Beni- Suef Teaching Hospital , Beni -Suef University.

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 21542873 (View on PubMed)

Other Identifiers

FMBSUREC/05032019/ELMoutaz

Identifier Type: -

Identifier Source: org_study_id