IcuNCT07204821
Functional Inspiratory Versus Expiratory Muscle Electrical Stimulation on Weaning Outcomes in Mechanically Ventilated Patients
A study testing Inspiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulator, Expiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulator and Early rehabilitation program in people with Icu, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The Goal of This Clinical Trail is To find out the difference in the effect of inspiratory muscle functional electrical stimulation and expiratory muscle functional electrical stimulation on weaning outcomes mechanically ventilated patients. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Icu
- What is being tested?
- Inspiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulator, Expiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulator and Early rehabilitation program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2026to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All mechanically ventilated patients will be:
- Their ages range from 45 to 65 years.
- Their BMI is from 25-29.9kg/m2.
- Mechanically ventilated for at least 24 hours.
- They all have hypoxemic respiratory failure
- Glasgow coma score (GCS) ranged from 6 to 12.
- Richmond Agitation-Sedation Scale score: -2 to +2
- Patients and their relatives had written informed consent.
Who cannot join
- Hemodynamically unstable patients.
- Patients with rib fractures.
- Patients with implanted pacemaker.
- Obese (BMI greater than 30 kgm2).
- Tachycardia.
- Uncontrolled hypertension.
Show all 16Show fewer
- History of neuromuscular disease at admission.
- Spinal injuries.
- Inability to trigger mechanical ventilation
- Pregnancy
- An anticipated stay on the ventilator <72 h at the time of study
- Patients who cannot attach electrodes due to local skin damage or infection
- Patients with Severe intestinal gas accumulation, structural abnormalities, and other reasons that prevent ultrasound detection of diaphragm movement.
- Congenital myopathies or neuropathies, and contraindications for expiratory muscle FES (cardiac pacemaker, refractory epilepsy, recent (< 4 weeks) abdominal surgery).
- Patients with unrelieved pneumothorax and restricted diaphragm movement disorders.
- Chest or diaphragm malformation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Beni-Suef University, Beni-Suef
Cairo
Sherine H Mehani, Professor, 00201003378217, drsherinm@gmail.com
Mahmoud I Mahmoud, Lecturer, 00201142998414, Mahmoud.ibrahim@pt.bsu.edu.eg
About this study
The Goal of This Clinical Trail is
- To find out the difference in the effect of inspiratory muscle functional electrical stimulation and expiratory muscle functional electrical stimulation on weaning outcomes mechanically ventilated patients.
- To investigate the effect of inspiratory muscle functional electrical stimulation and expiratory muscle functional electrical stimulation on Laboratory investigation (Arterial Blood Gases).
- To investigate the effect of inspiratory muscle functional electrical stimulation and expiratory muscle functional electrical stimulation on Sonar parameters (Diaphragmatic excursion, Diaphragmatic muscle fractional thickness in the end of inspiration and the end of expiration and abdominal muscles wall thickness). To evaluate the effect of inspiratory muscle functional electrical stimulation and expiratory muscle functional electrical stimulation on (ICU length of stay and Spontaneous Breathing Trail (SBT)).
Read the detailed description
Type of Study: This study will be randomized clinical trial. Study Procedures: 100 mechanically ventilated both sexes patients will be recruited in this study from intensive care unit, Beni-Suef University Hospital, their ages range from 45 to 65 years.
The selected patients will be all mechanically ventilated due to respiratory failure and randomly Participants will be randomly assigned to the three study groups and one control group . We will prepare (100) identical envelops, (25) of them will be filled with a label identifying Group (A) with all instruction details, while the second (25) will be filled with a label identifying the Group (B), the third (25) will be filled with a label identifying the Group (C), the last (25) will be filled with a label identifying the Group (D). All envelops will be prepared by the investigator and sealed before starting enrollment:
- Study group (A) include mechanically ventilated patients will receive Inspiratory muscle functional electrical stimulation along with Early rehabilitation program plus medical treatment.
- Study group (B) include mechanically ventilated patients will receive Expiratory muscle functional electrical stimulation along with Early rehabilitation program plus medical treatment.
- Study group (C) include mechanically ventilated patients will receive Inspiratory muscle functional electrical stimulation and Expiratory muscle functional electrical stimulation along with Early rehabilitation program plus medical treatment.
- Control group (D) include mechanically ventilated patients will receive early rehabilitation program plus medical treatment.
- Measurement procedures:
- ICU length of stay: The number of days from ICU admission to ICU discharges
- Monitoring :
- Mode of ventilation parameters:
- Fiao2 ii) PEEP iii) Tidal Volume iv) Respiratory Rate v) Maximum Respiratory Pressure
- The Duration and Type of Weaning: The Classification of patients according to the weaning process: Classification of patients according to the difficulty and length of the weaning process into 3 Groups: 1- Simple weaning Patients who proceed from initiation of weaning to successful extubation on the first attempt without difficulty 2- Difficult weaning Patients who fail initial weaning and require up to three SBT or as long as 7 days from the first SBT to achieve successful weaning 3- Prolonged weaning Patients who fail at least three weaning attempts or require 7 days of weaning after the first SBT
- Laboratory investigation : Arterial Blood Gases (ABG): ABG may show hypoxemia that increased oxygen supplementation and hypercapnia. The analysis will be used as initial evaluation 10 minutes before the session and final evaluation 20 minutes after the end of the session. The samples will be drawn from radial artery with a preheparinized syringe. All the samples will be analyzed for: pH, PaO2, SaO2, PaCO2, and HCO3.
- Sonar parameters:
- Diaphragmatic excursion.
- Diaphragmatic muscle fractional thickness in the end of inspiration and the end of expiration.
- Abdominal muscles wall thickness.
- Spontaneous Breathing Trail (SBT) Is a process that allows patients to breathe spontaneously with minimal or no ventilatory support for predefined of time (e.g. 30 min) to assess the patient readiness for extubation
- Conditions
- Icu
- Being tested
- Inspiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulator, Expiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulator, Early rehabilitation program
- Keywords
- Functional Inspiratory Muscle Electrical Stimulation, Functional Expiratory Muscle Electrical Stimulation, Weaning Outcomes in Mechanically Ventilated Patients.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulatorDevice
The electrical current is pulsed, biphasic, and symmetric, with the Frequency of 30 hertz, Phase width of 200µs, ON time 2s: OFF time 3s. Patients will be instructed to keep their RR constant and to coordinate their breathing with the pulsing of the electrical current. The intensity of the current is the minimum necessary to obtain diaphragm muscle contraction . Four silicone-carbon electrodes (4x4cm) were placed on the clean skin with gel. 2 electrodes each will be placed above and below the right and left sides of the xiphoid process within the seventh and eighth anterior intercostal space. In addition, two electrodes each were placed on the right and left midaxillary line of the seventh and eighth anterior intercostal space Two sessions daily, each session will last for 30 minutes; the patients remained in the semi-Fowler position 30 º with the lower extremities extended and arms alongside the body
Expiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulatorDevice
FES is applied for 30 min, 2 sessions daily, until patients are weaned from mechanical ventilation, but no longer than 6 weeks.Stimulation will be applied via surface electrodes on the abdominal wall Four pairs silicone-carbon electrodes (4x9cm) were placed on the clean skin with gel, and stimulation intensity will be titrated in order to activate the external oblique, internal oblique, transversus abdominis and Rectus abdominis muscles. The patient's tolerance of expiratory muscle FES is continuously monitored;Frequency 30 Hz, pulse width 352 µs and intensity set to cause strong muscle contraction, with a maximum intensity initially set at 60 mA (tolerated intensity in healthy volunteers). Then we amend the protocol to allow a maximum intensity of 100 mA .Strong muscle contraction will verify (visible and palpable) every ten minutes throughout each FES session, and if necessary, stimulation intensity was increased.
Early rehabilitation programDevice
Rehabilitation therapy which consisted of six levels:
Level 0 turning over once every 2 h for unconscious patients with unstable vital signs level 1-2 in addition to turning over, maintaining joint range of motion to prevent muscle atrophy, and placing normal limb position for conscious patients who could sit up for at least 20 min, 2 times a day Level 3 similar to level 2, but sitting on the edge of the bed for patients who could perform upper-limb anti-gravity training Level 4 similar to level 3, but standing up or sitting in a chair for at least 20 min a day for patients who could perform lower-limb anti-gravity training Level 5 patients actively moved from the bed and walked bedside
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Inspiratory muscle FES by Flexistem Digital electrical muscle stimulator +Early rehabilitation program. The current is pulsed, biphasic, and symmetric, with Frequency of 30 hertz , Phase width of 200µs, ON time 2s: OFF time 3s. Patients will be instructed to keep their RR constant and to coordinate their breathing with the pulsing of the electrical current . Four silicone-carbon electrodes (4x4cm) were placed on the clean skin with gel. Two electrodes each will be placed above and below the right and left sides of the xiphoid process within the seventh and eighth anterior intercostal space. In addition, two electrodes each were placed on the right and left midaxillary line of the seventh and eighth anterior space Two sessions daily, each session will last for 30 minutes; the patients remained in the semi-Fowler position 30 º with the lower extremities extended and arms alongside the body Receives: Device: Inspiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulator; Device: Early rehabilitation program |
| Group B | Active comparator | Expiratory muscle FES by Flexistem Digital electrical muscle stimulator+Early rehabilitation program. FES is applied for 30 min, two sessions daily, until patients are weaned from mechanical ventilation, but no longer than six weeks. Stimulation will be applied during exhalation and via surface electrodes on the abdominal wall Four pairs silicone-carbon electrodes (4x9cm) were placed on the clean skin with gel, and stimulation intensity will be titrated in order to activate the external oblique, internal oblique, transversus abdominis and Rectus abdominis muscles. settings are as follows: Frequency 30 Hz, pulse width 352 µs and a current intensity set to cause strong muscle contraction, with a maximum intensity initially set at 60 mA . Then we amend the protocol to allow a maximum intensity of 100 mA . Strong muscle contraction will verify (visible and palpable) every ten minutes throughout each FES session, and if necessary, stimulation intensity was increased. Receives: Device: Expiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulator; Device: Early rehabilitation program |
| Group C | Active comparator | Inspiratory muscle functional electrical stimulation and Expiratory muscle functional electrical stimulation along with Early rehabilitation program plus medical treatment. Receives: Device: Inspiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulator; Device: Expiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulator; Device: Early rehabilitation program |
| Group D (Control Group) | Active comparator | early rehabilitation program plus medical treatment
Rehabilitation therapy which consisted of six levels:
Level 0 turning over once every 2 h for unconscious patients with unstable vital signs level 1-2 in addition to turning over, maintaining joint range of motion to prevent muscle atrophy, and placing normal limb position for conscious patients who could sit up for at least 20 min, 2 times a day Level 3 similar to level 2, but sitting on the edge of the bed for patients who could perform upper-limb anti-gravity training Level 4 similar to level 3, but standing up or sitting in a chair for at least 20 min a day for patients who could perform lower-limb anti-gravity training Level 5 patients actively moved from the bed and walked bedside Receives: Device: Early rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
pH (arterial blood gas)
Measured: Baseline (within 24 hours prior to intervention) and at successful weaning from mechanical ventilation (within 24 hours of extubation).
PaO₂ (mmHg, arterial blood gas)
Measured: Baseline (within 24 hours prior to intervention) and at successful weaning from mechanical ventilation (within 24 hours of extubation).
PaCO₂ (mmHg, arterial blood gas)
Measured: Baseline (within 24 hours prior to intervention) and at successful weaning from mechanical ventilation (within 24 hours of extubation).
SaO₂ (%)
Measured: Baseline (within 24 hours prior to intervention) and at successful weaning from mechanical ventilation (within 24 hours of extubation)
HCO₃ (mmol/L, arterial blood gas)
Measured: Baseline (within 24 hours prior to intervention) and at successful weaning from mechanical ventilation (within 24 hours of extubation)
Secondary outcomes (3)
Diaphragmatic Excursion
Measured: Baseline at the start of the study "baseline" and after Successful weaning from mechanical ventilation
Diaphragmatic Fractional Thickness
Measured: Baseline at the start of the study "baseline" and after Successful weaning from mechanical ventilation
Abdominal Muscles Wall Thickness
Measured: Baseline at the start of the study and after Successful weaning from mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start15 Jun 2026 (estimated)
- Primary completion15 Jun 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IcuStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayah Japer Muhammad Muhammad Abu-Bakr, Beni-Suef University
- Investigators
- Sherine H Mehani, Professor, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204821
- Sponsor's protocol ID
- ICU
- Status last verified
- Jun 2026
- First submitted
- 23 Sep 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Inspiratory Versus Expiratory Muscle Electrical Stimulation on Weaning Outcomes in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT07204821
- Acronym / sponsor ID
- ICU
- Conditions
- Icu
- Keywords
- Functional Inspiratory Muscle Electrical Stimulation, Functional Expiratory Muscle Electrical Stimulation, Weaning Outcomes in Mechanically Ventilated Patients.
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 2 Oct 2025 (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.
The Goal of This Clinical Trail is
- To find out the difference in the effect of inspiratory muscle functional electrical stimulation and expiratory muscle functional electrical stimulation on weaning outcomes mechanically ventilated patients.
- To investigate the effect of inspiratory muscle functional electrical stimulation and expiratory muscle functional electrical stimulation on Laboratory investigation (Arterial Blood Gases).
- To investigate the effect of inspiratory muscle functional electrical stimulation and expiratory muscle functional electrical stimulation on Sonar parameters (Diaphragmatic excursion, Diaphragmatic muscle fractional thickness in the end of inspiration and the end of expiration and abdominal muscles wall thickness). To evaluate the effect of inspiratory muscle functional electrical stimulation and expiratory muscle functional electrical stimulation on (ICU length of stay and Spontaneous Breathing Trail (SBT)).
Detailed description
Type of Study: This study will be randomized clinical trial. Study Procedures: 100 mechanically ventilated both sexes patients will be recruited in this study from intensive care unit, Beni-Suef University Hospital, their ages range from 45 to 65 years.
The selected patients will be all mechanically ventilated due to respiratory failure and randomly Participants will be randomly assigned to the three study groups and one control group . We will prepare (100) identical envelops, (25) of them will be filled with a label identifying Group (A) with all instruction details, while the second (25) will be filled with a label identifying the Group (B), the third (25) will be filled with a label identifying the Group (C), the last (25) will be filled with a label identifying the Group (D). All envelops will be prepared by the investigator and sealed before starting enrollment:
- Study group (A) include mechanically ventilated patients will receive Inspiratory muscle functional electrical stimulation along with Early rehabilitation program plus medical treatment.
- Study group (B) include mechanically ventilated patients will receive Expiratory muscle functional electrical stimulation along with Early rehabilitation program plus medical treatment.
- Study group (C) include mechanically ventilated patients will receive Inspiratory muscle functional electrical stimulation and Expiratory muscle functional electrical stimulation along with Early rehabilitation program plus medical treatment.
- Control group (D) include mechanically ventilated patients will receive early rehabilitation program plus medical treatment.
- Measurement procedures:
- ICU length of stay: The number of days from ICU admission to ICU discharges
- Monitoring :
- Mode of ventilation parameters:
- Fiao2 ii) PEEP iii) Tidal Volume iv) Respiratory Rate v) Maximum Respiratory Pressure
- The Duration and Type of Weaning: The Classification of patients according to the weaning process: Classification of patients according to the difficulty and length of the weaning process into 3 Groups: 1- Simple weaning Patients who proceed from initiation of weaning to successful extubation on the first attempt without difficulty 2- Difficult weaning Patients who fail initial weaning and require up to three SBT or as long as 7 days from the first SBT to achieve successful weaning 3- Prolonged weaning Patients who fail at least three weaning attempts or require 7 days of weaning after the first SBT
- Laboratory investigation : Arterial Blood Gases (ABG): ABG may show hypoxemia that increased oxygen supplementation and hypercapnia. The analysis will be used as initial evaluation 10 minutes before the session and final evaluation 20 minutes after the end of the session. The samples will be drawn from radial artery with a preheparinized syringe. All the samples will be analyzed for: pH, PaO2, SaO2, PaCO2, and HCO3.
- Sonar parameters:
- Diaphragmatic excursion.
- Diaphragmatic muscle fractional thickness in the end of inspiration and the end of expiration.
- Abdominal muscles wall thickness.
- Spontaneous Breathing Trail (SBT) Is a process that allows patients to breathe spontaneously with minimal or no ventilatory support for predefined of time (e.g. 30 min) to assess the patient readiness for extubation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Inspiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulator, Device: Early rehabilitation programInspiratory muscle FES by Flexistem Digital electrical muscle stimulator +Early rehabilitation program. The current is pulsed, biphasic, and symmetric, with Frequency of 30 hertz , Phase width of 200µs, ON time 2s: OFF time 3s. Patients will be instructed to keep their RR constant and to coordinate their breathing with the pulsing of the electrical current . Four silicone-carbon electrodes (4x4cm) were placed on the clean skin with gel. Two electrodes each will be placed above and below the right and left sides of the xiphoid process within the seventh and eighth anterior intercostal space. In addition, two electrodes each were placed on the right and left midaxillary line of the seventh and eighth anterior space Two sessions daily, each session will last for 30 minutes; the patients remained in the semi-Fowler position 30 º with the lower extremities extended and arms alongside the body |
| Group B | Active comparator | Device: Expiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulator, Device: Early rehabilitation programExpiratory muscle FES by Flexistem Digital electrical muscle stimulator+Early rehabilitation program. FES is applied for 30 min, two sessions daily, until patients are weaned from mechanical ventilation, but no longer than six weeks. Stimulation will be applied during exhalation and via surface electrodes on the abdominal wall Four pairs silicone-carbon electrodes (4x9cm) were placed on the clean skin with gel, and stimulation intensity will be titrated in order to activate the external oblique, internal oblique, transversus abdominis and Rectus abdominis muscles. settings are as follows: Frequency 30 Hz, pulse width 352 µs and a current intensity set to cause strong muscle contraction, with a maximum intensity initially set at 60 mA . Then we amend the protocol to allow a maximum intensity of 100 mA . Strong muscle contraction will verify (visible and palpable) every ten minutes throughout each FES session, and if necessary, stimulation intensity was increased. |
| Group C | Active comparator | Device: Inspiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulator, Device: Expiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulator, Device: Early rehabilitation programInspiratory muscle functional electrical stimulation and Expiratory muscle functional electrical stimulation along with Early rehabilitation program plus medical treatment. |
| Group D (Control Group) | Active comparator | Device: Early rehabilitation programearly rehabilitation program plus medical treatment Rehabilitation therapy which consisted of six levels: Level 0 turning over once every 2 h for unconscious patients with unstable vital signs level 1-2 in addition to turning over, maintaining joint range of motion to prevent muscle atrophy, and placing normal limb position for conscious patients who could sit up for at least 20 min, 2 times a day Level 3 similar to level 2, but sitting on the edge of the bed for patients who could perform upper-limb anti-gravity training Level 4 similar to level 3, but standing up or sitting in a chair for at least 20 min a day for patients who could perform lower-limb anti-gravity training Level 5 patients actively moved from the bed and walked bedside |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- All mechanically ventilated patients will be:
- Their ages range from 45 to 65 years.
- Their BMI is from 25-29.9kg/m2.
- Mechanically ventilated for at least 24 hours.
- They all have hypoxemic respiratory failure
Key exclusion criteria (16 listed)
- Hemodynamically unstable patients.
- Patients with rib fractures.
- Patients with implanted pacemaker.
- Obese (BMI greater than 30 kgm2).
- Tachycardia.
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 |
|---|---|---|
| Inspiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulatorThe electrical current is pulsed, biphasic, and symmetric, with the Frequency of 30 hertz, Phase width of 200µs, ON time 2s: OFF time 3s. Patients will be instructed to keep their RR constant and to coordinate their breathing with the pulsing of the electrical current. The intensity of the current is the minimum necessary to obtain diaphragm muscle contraction . Four silicone-carbon electrodes (4x4cm) were placed on the clean skin with gel. 2 electrodes each will be placed above and below the right and left sides of the xiphoid process within the seventh and eighth anterior intercostal space. In addition, two electrodes each were placed on the right and left midaxillary line of the seventh and eighth anterior intercostal space Two sessions daily, each session will last for 30 minutes; the patients remained in the semi-Fowler position 30 º with the lower extremities extended and arms alongside the body | Device | Group A, Group C |
| Expiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulatorFES is applied for 30 min, 2 sessions daily, until patients are weaned from mechanical ventilation, but no longer than 6 weeks.Stimulation will be applied via surface electrodes on the abdominal wall Four pairs silicone-carbon electrodes (4x9cm) were placed on the clean skin with gel, and stimulation intensity will be titrated in order to activate the external oblique, internal oblique, transversus abdominis and Rectus abdominis muscles. The patient's tolerance of expiratory muscle FES is continuously monitored;Frequency 30 Hz, pulse width 352 µs and intensity set to cause strong muscle contraction, with a maximum intensity initially set at 60 mA (tolerated intensity in healthy volunteers). Then we amend the protocol to allow a maximum intensity of 100 mA .Strong muscle contraction will verify (visible and palpable) every ten minutes throughout each FES session, and if necessary, stimulation intensity was increased. | Device | Group B, Group C |
| Early rehabilitation programRehabilitation therapy which consisted of six levels: Level 0 turning over once every 2 h for unconscious patients with unstable vital signs level 1-2 in addition to turning over, maintaining joint range of motion to prevent muscle atrophy, and placing normal limb position for conscious patients who could sit up for at least 20 min, 2 times a day Level 3 similar to level 2, but sitting on the edge of the bed for patients who could perform upper-limb anti-gravity training Level 4 similar to level 3, but standing up or sitting in a chair for at least 20 min a day for patients who could perform lower-limb anti-gravity training Level 5 patients actively moved from the bed and walked bedside | Device | Group A, Group B, Group C, Group D (Control Group) |
Primary outcome
pH (arterial blood gas)
Time frame: Baseline (within 24 hours prior to intervention) and at successful weaning from mechanical ventilation (within 24 hours of extubation).
PaO₂ (mmHg, arterial blood gas)
Time frame: Baseline (within 24 hours prior to intervention) and at successful weaning from mechanical ventilation (within 24 hours of extubation).
PaCO₂ (mmHg, arterial blood gas)
Time frame: Baseline (within 24 hours prior to intervention) and at successful weaning from mechanical ventilation (within 24 hours of extubation).
SaO₂ (%)
Time frame: Baseline (within 24 hours prior to intervention) and at successful weaning from mechanical ventilation (within 24 hours of extubation)
HCO₃ (mmol/L, arterial blood gas)
Time frame: Baseline (within 24 hours prior to intervention) and at successful weaning from mechanical ventilation (within 24 hours of extubation)
3 secondary outcomes
Diaphragmatic Excursion
Time frame: Baseline at the start of the study "baseline" and after Successful weaning from mechanical ventilation
Diaphragmatic Fractional Thickness
Time frame: Baseline at the start of the study "baseline" and after Successful weaning from mechanical ventilation
Abdominal Muscles Wall Thickness
Time frame: Baseline at the start of the study and after Successful weaning from mechanical ventilation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Sherine H Mehani, Professor principal investigator
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 Inspiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulator, Expiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulator and Early rehabilitation program in people with Icu, run by Beni-Suef University 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 8 inclusion and 16 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: opening soon, as of the sponsor's last update on 3 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayah J Abu-Bakr, Master Degree (00201070330453 ext. 00201113698639, dinajaper2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pH (arterial blood gas) (time frame: Baseline (within 24 hours prior to intervention) and at successful weaning from mechanical ventilation (within 24 hours of extubation).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2026.