Effect of Electrical Diaphragmatic Stimulation on Chronic Obstructive Pulmonary Disease

Not Applicable

Active, not recruiting

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

• Registration Number: NCT07020299
• Lead Sponsor: Mansoura University Hospital

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2024-08-01
• Primary Completion: 2025-02-01
• Study First Submitted: 2025-05-27
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary outcome is the progression to invasive mechanical ventilation(IMV)	6 months	Functional assessment by US measurement of diaphragmatic excursion and thickness fraction in (cm) including base line measurement and post treatment measurement ( at the end of admission).

Secondary Outcome Measures

Name	Time	Method
The secondary outcomes is the duration of ICU admission	12 months	The secondary outcomes is the duration of ICU admission (days), the immediate effect of TEDS and after sessions.

Trial Locations

Locations (1)

Faculty of medicine mansoura university; 🇪🇬 Mansoura, Egypt