Mechanical Ventilation ComplicationNCT04021615
Rehabilitation Program for Weaning From Mechanical Ventilator
A study testing Comprehensive physical therapy rehabilitation program combined with inspiratory muscle training and Traditional chest physical therapy rehabilitation program combined with inspiratory muscle training in people with Mechanical Ventilation Complication, run by Sherin Hassan Mohammed Mehani at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- Comprehensive physical therapy rehabilitation program combined with inspiratory muscle training and Traditional chest physical therapy rehabilitation program combined with inspiratory muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Jul 2019to 10 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
surgical intensive care unit, Kasr Al Ainy Teaching Hospital, Cairo University and Beni- Suef Teaching Hospital , Beni -Suef University.
Cairo, Cairo Governorate, 62511
About this study
Official title: Comprehensive Rehabilitation Program Versus Traditional Chest Physiotherapy for Weaning From Mechanical Ventilator
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?
Read more
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.
Read the 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
- Being tested
- Comprehensive physical therapy rehabilitation program combined with inspiratory muscle training, Traditional chest physical therapy rehabilitation program combined with inspiratory muscle training
- Keywords
- rehabilitation, difficult weaning, emergency abdominal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive physical therapy rehabilitation program combined with inspiratory muscle trainingOther
Also called Comprehensive physical therapy rehabilitation program
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 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
Traditional chest physical therapy rehabilitation program combined with inspiratory muscle trainingOther
Also called Traditional physical therapy rehabilitation program
The same inspiratory muscle training for the study group combined with the traditional physical therapy program consist of positioning , modified postural drainage , percussion , vibration.
| Study group | Role | What they receive |
|---|---|---|
| Group A (study group) | Experimental | Forty-five patients will receive a comprehensive rehabilitation programme combined with inspiratory muscle training. Receives: Other: Comprehensive physical therapy rehabilitation program combined with inspiratory muscle training |
| Group B (Control group) | Active comparator | Forty-five patients will receive traditional chest physical therapy combined with inspiratory muscle training. Receives: Other: Traditional chest physical therapy rehabilitation program combined with inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: at baseline and at immediately before the spontaneous breathing trial
Secondary outcomes (5)
Upper and lower extremity muscle strength
Upper and lower extremity muscle strength will be assessed using a handheld dynamometer. The shoulder flexor, elbow flexor, and knee extensor muscle groups w ill be included in the measurements. Standard test positions will be modified because all patients in this study are using mechanical ventilator and unable to sit up at initial examination. The shoulder and elbow flexors will be tested in the semi-Fowler position. The isometric force of the shoulder flexors will be tested with the shoulder flexed 90 degrees and the elbow in extended position. The dynamometer will be placed just proximal to the epicondyles of the humerus, and the patients will be stabilized at the axillary region. The isometric force of the elbow flexors will be tested with the elbow flexed 90 degrees, the forearm supinated, and the shoulder in neutral position; the dynamometer will be placed just proximal to styloid processes of ulna and radius, and the patients will be stabilized at the superior aspect of
Measured: at baseline and at 30 days maximum or until extubation from mechanical ventilator successfully
The Functional Independence Measure (FIM)
5 activities with The Functional Independence Measure (FIM) were measured, which are bathing, dressing, moving from bed to chair, bowel management, and bladder management.
Measured: at baseline and at 30 days maximum or until extubation from mechanical ventilator successfully
Rapid shallow breathing index (RSBI)
The rapid shallow breathing index (RSBI) was determined by dividing the number of breaths per minute (f) by the tidal volume (TV) in liters obtained from a mechanical ventilator
Measured: at baseline and immediately before the spontaneous breathing trial
Pain level
were assessed using a 10 cm visual analog scale (VAS). Participants evaluated their pain intensity on a scale from 0 (no pain) to 10 (most severe pain possible).
Measured: at baseline and at 30 days maximum or until extubation from mechanical ventilator successfully
days to wean
Number of days to weaning
Measured: at baseline and at 30 days maximum or until extubation from mechanical ventilator successfully
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start21 Jul 2019
- Primary completion5 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Ninety general surgery patients who are difficult and prolonged weaning patients from both sexes (men \& women) with age more than 18 years old in the surgical intensive care unit, Kasr Al Ainy Teaching Hospital, Cairo University and Beni- Suef Teaching Hospital , Beni -Suef University.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sherin Hassan Mohammed Mehani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherin Hassan Mohammed Mehani, Beni-Suef University
- Investigators
- Hatem ELMoutaz, Professor, Study director, Faculty of Medicine , Beni -Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021615
- Sponsor's protocol ID
- FMBSUREC/05032019/ELMoutaz
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2019
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Description for inclusion and exclusion criteria , procedure for evaluating outcomes and intervention in details
Publications
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.
PubMed 21542873
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Rehabilitation Program Versus Traditional Chest Physiotherapy for Weaning From Mechanical Ventilator
- ClinicalTrials.gov ID
- NCT04021615
- Acronym / sponsor ID
- FMBSUREC/05032019/ELMoutaz
- Conditions
- Mechanical Ventilation Complication
- Keywords
- rehabilitation, difficult weaning, emergency abdominal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sherin Hassan Mohammed MehaniUniversity, hospital or other
- Study start
- 21 Jul 2019 (actual)
- Primary completion
- 5 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 16 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Ninety general surgery patients who are difficult and prolonged weaning patients from both sexes (men \& women) with age more than 18 years old in the surgical intensive care unit, Kasr Al Ainy Teaching Hospital, Cairo University and Beni- Suef Teaching Hospital , Beni -Suef University.
| Arm | Type | Receives |
|---|---|---|
| Group A (study group) | Experimental | Other: Comprehensive physical therapy rehabilitation program combined with inspiratory muscle trainingForty-five patients will receive a comprehensive rehabilitation programme combined with inspiratory muscle training. |
| Group B (Control group) | Active comparator | Other: Traditional chest physical therapy rehabilitation program combined with inspiratory muscle trainingForty-five patients will receive traditional chest physical therapy combined with inspiratory muscle training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive physical therapy rehabilitation program combined with inspiratory muscle trainingAlso: Comprehensive physical therapy rehabilitation programA 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 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 | Other | Group A (study group) |
| Traditional chest physical therapy rehabilitation program combined with inspiratory muscle trainingAlso: Traditional physical therapy rehabilitation programThe same inspiratory muscle training for the study group combined with the traditional physical therapy program consist of positioning , modified postural drainage , percussion , vibration. | Other | Group B (Control group) |
Primary outcome
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: 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
5 secondary outcomes
Upper and lower extremity muscle strength
Time frame: at baseline and at 30 days maximum or until extubation from mechanical ventilator successfully
The Functional Independence Measure (FIM)
Time frame: at baseline and at 30 days maximum or until extubation from mechanical ventilator successfully
Rapid shallow breathing index (RSBI)
Time frame: at baseline and immediately before the spontaneous breathing trial
Pain level
Time frame: at baseline and at 30 days maximum or until extubation from mechanical ventilator successfully
days to wean
Time frame: at baseline and at 30 days maximum or until extubation from mechanical ventilator successfully
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Background: PubMed 21542873Nava 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.
- Individual participant dataSharing planned: Yes. Description for inclusion and exclusion criteria , procedure for evaluating outcomes and intervention in details
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hatem ELMoutaz, Professor study director
Faculty of Medicine , Beni -Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive physical therapy rehabilitation program combined with inspiratory muscle training and Traditional chest physical therapy rehabilitation program combined with inspiratory muscle training in people with Mechanical Ventilation Complication, run by Sherin Hassan Mohammed Mehani at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of successful weaning in both groups (time frame: 30 days maximum or until extubation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04021615, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.