Effect of Electrical Diaphragmatic Stimulation on Chronic Obstructive Pulmonary Disease

Mansoura University Hospital

Status: Active, not recruiting

Conditions: COPD (Chronic Obstructive Pulmonary Disease); Diaphragm Electrical Activity

Treatments: Device: Device : Digital electrical muscle stimulator is applied to induce diaphragm contraction.

Study type: Interventional

Funder types: Other

Identifiers

NCT07020299

MD.24.08.878

Details and patient eligibility

About

Respiratory muscle dysfunction is a common consequence of chronic obstructive pulmonary disease (COPD).

This technique consists of placing electrodes on the skin at locations near the motor points of the diaphragm, transmitting an intermittent current, and generating action potentials capable of producing muscle contractions

Full description

Respiratory muscle dysfunction is a common consequence of chronic obstructive pulmonary disease (COPD).Weakness or fatigue of the diaphragm and accessory muscles of inspiration is widely recognized in patients on mechanical ventilation. There is increasing evidence to show mechanical ventilation itself may adversely affect the diaphragm's structure and function, which has been termed ventilator-induced diaphragmatic dysfunction. However, in patients with more severe COPD, the benefits of rehabilitation may be limited. In this context, there are new approaches to PR, such as electrical stimulation, a technique that externally stimulates contractions of peripheral muscles to improve peripheral muscle function in patients with severe COPD. This technique consists of placing electrodes on the skin at locations near the motor points of the diaphragm, transmitting an intermittent current, and generating action potentials capable of producing muscle contractions

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18 years.
• Known cases of COPD admitted at respiratory critical care unit with severe acute exacerbation (defined according to GOLD 2024).

Exclusion criteria

• Body mass index (BMI) > 35 kg/m2
• Post arrest patients
• Brain death
• Hemodynamic instability
• Invasive MV
• Lung disease other than COPD
• Pregnancy , ascitis.
• History of neuromuscular disease at admission
• Spinal injuries
• Skin lesions or an open lesion in the regions where the electrodes would be placed
• Use of pacemakers
• Patients on maintenance steroid therapy
• Depletating disease as malignancy 14. Patients refusing the procedure

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

TEDS group will be subjected to sessions of TEDS

Active Comparator group

Description:

TEDS group will be subjected to sessions of TEDS as follow : Digital electrical muscle stimulator (EV-906 Digital TENS/EMS made in TAIWAN) is applied to induce diaphragm contraction.

Treatment:

Device: Device : Digital electrical muscle stimulator is applied to induce diaphragm contraction.

Non TEDS group will not be subjected to sessions of TEDS

No Intervention group

Description:

Non TEDS group will not be subjected to sessions of TEDS