Functional Inspiratory Versus Expiratory Muscle Electrical Stimulation on Weaning Outcomes in Mechanically Ventilated Patients

NCT07204821 | Not Yet Recruiting

• 1 other identifier: ICU
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.
• 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)).

Conditions

Icu

Keywords

Functional Inspiratory Muscle Electrical Stimulation, Functional Expiratory Muscle Electrical Stimulation, Weaning Outcomes in Mechanically Ventilated Patients.

Outcome Measures

Primary Outcomes (5)

• pH (arterial blood gas)

  Baseline (within 24 hours prior to intervention) and at successful weaning from mechanical ventilation (within 24 hours of extubation).

• PaO₂ (mmHg, arterial blood gas)

  Baseline (within 24 hours prior to intervention) and at successful weaning from mechanical ventilation (within 24 hours of extubation).

• PaCO₂ (mmHg, arterial blood gas)

  Baseline (within 24 hours prior to intervention) and at successful weaning from mechanical ventilation (within 24 hours of extubation).

• SaO₂ (%)

  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)

  Baseline (within 24 hours prior to intervention) and at successful weaning from mechanical ventilation (within 24 hours of extubation)

Secondary Outcomes (3)

• Diaphragmatic Excursion

  Baseline at the start of the study "baseline" and after Successful weaning from mechanical ventilation

• Diaphragmatic Fractional Thickness

  Baseline at the start of the study "baseline" and after Successful weaning from mechanical ventilation

• Abdominal Muscles Wall Thickness

  Baseline at the start of the study and after Successful weaning from mechanical ventilation

Study Arms (4)

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

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.

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.

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

Device: Early rehabilitation program

Interventions

Inspiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulator DEVICE

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

Group A; Group C

Expiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulator DEVICE

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.

Group B; Group C

Early rehabilitation program DEVICE

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

Group A; Group B; Group C; Group D (Control Group)

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Hemodynamically unstable patients.
• Patients with rib fractures.
• Patients with implanted pacemaker.
• Obese (BMI greater than 30 kgm2).
• Tachycardia.
• Uncontrolled hypertension.
• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef University, Beni-Suef

Cairo, Egypt

Location

Study Officials

• Sherine H Mehani, Professor

  Beni-Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayah J Abu-Bakr, Master Degree

CONTACT

00201070330453; dinajaper2@gmail.com

Mahmoud I Mahmoud, Lecturer

CONTACT

00201142998414; Mahmoud.ibrahim@pt.bsu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapist

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 2, 2025
• Study Start: January 1, 2026
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)