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

Not Applicable

Not yet recruiting

• Conditions: Icu

• Registration Number: NCT07204821
• Lead Sponsor: Beni-Suef University

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)).

Detailed Description

Type of Study: This study will be randomized clinical trial. Study Procedures: 48 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 (48) identical envelops, (12) of them will be filled with a label identifying Group (A) with all instruction details, while the second (12) will be filled with a label identifying the Group (B), the third (12) will be filled with a label identifying the Group (C), the last (12) will be filled with a label identifying the Group (D). All envelops will be prepared by the investigator and sealed before starting enrollment:

1. Study group (A) include mechanically ventilated patients will receive Inspiratory muscle functional electrical stimulation along with Early rehabilitation program plus medical treatment.

2. Study group (B) include mechanically ventilated patients will receive Expiratory muscle functional electrical stimulation along with Early rehabilitation program plus medical treatment.

3. 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.

4. Control group (D) include mechanically ventilated patients will receive early rehabilitation program plus medical treatment.

A) Measurement procedures:

1. ICU length of stay: The number of days from ICU admission to ICU discharges

2. Monitoring :

* Mode of ventilation parameters:

i) 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

3. 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.

4. Sonar parameters:

* Diaphragmatic excursion.

* Diaphragmatic muscle fractional thickness in the end of inspiration and the end of expiration.

* Abdominal muscles wall thickness.

5. 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 Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-23
• Study Start: 2025-09-30
• Study First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Primary Completion: 2025-11-30
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Chest or diaphragm malformation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Diaphragmatic Excursion	at the start of the study and after Successful weaning from mechanical ventilation
Diaphragmatic Fractional Thickness	at the start of the study and after Successful weaning from mechanical ventilation
Abdominal Muscles Wall Thickness	at the start of the study and after Successful weaning from mechanical ventilation

Trial Locations

Locations (1)

Beni-Suef University, Beni-Suef; 🇪🇬 Cairo, Egypt