Rehabilitation Program for Weaning From Mechanical Ventilator

NCT04021615 | Completed DMC

• 1 other identifier: FMBSUREC/05032019/ELMoutaz
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation Complication

Keywords

rehabilitation; general surgery; difficult weaning

Outcome Measures

Primary Outcomes (2)

• percentage of successful weaning in both groups

  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

  30 days maximum or until extubation

• inspiratory muscle strength (MIP)

  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

  30 days maximum or until extubation

Secondary Outcomes (2)

• Upper and lower extremity muscle strength

  30 days maximum or until extubation from mechanical ventilator successfully

• The Functional Independence Measure (FIM)

  30 days maximum or until extubation

Study Arms (2)

Group A (study group)

EXPERIMENTAL

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

Other: Comprehensive physical therapy rehabilitation program combined with inspiratory muscle training

Group B (Control group)

ACTIVE COMPARATOR

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

Other: Traditional chest physical therapy rehabilitation program combined with inspiratory muscle training

Interventions

Comprehensive physical therapy rehabilitation program combined with inspiratory muscle training 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

Also known as: Comprehensive physical therapy rehabilitation program

Group A (study group)

Traditional chest physical therapy rehabilitation program combined with inspiratory muscle training 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.

Also known as: Traditional physical therapy rehabilitation program

Group B (Control group)

Eligibility Criteria

• Age: 40 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sherin Hassan Mohammed Mehani: lead

Study Sites (1)

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

Cairo, 62511, Egypt

Location

Related Publications (1)

• 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.

  PMID: 21542873 BACKGROUND

Study Officials

• Hatem ELMoutaz, Professor

  Faculty of Medicine , Beni -Suef University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chairman of Physical Therapy Department of Internal Medicine and Vic Dean for Education and Student Affairs , Faculty of Physical Therapy , Beni- Suef University

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2019
• First Posted: July 16, 2019
• Study Start: July 21, 2019
• Primary Completion: January 5, 2020
• Study Completion: January 10, 2020
• Last Updated: February 5, 2020

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2 months
• Access Criteria: I am willing to share data through my E- mail

Locations

EG (1)