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

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

Interventions

DEVICE

Inspiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulator

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

DEVICE

Expiratory muscle functional electrical stimulation by Flexistem Digital electrical muscle stimulator

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.

DEVICE

Early rehabilitation program

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

Sponsors & Collaborators

• Beni-Suef University

  lead OTHER

Principal Investigators

• Sherine H Mehani, Professor · Beni-Suef University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2026-02-01

Completion

2026-03-01

Countries

• Egypt

Study Locations