Clinical trial NCT07020299: Effect of Electrical Diaphragmatic Stimulation on Chronic Obstructive Pulmonary Disease
Official title: Effect of Trans-cutenuous Electrical Diaphragmatic Stimulation on Severe Chronic Obstructive Pulmonary Disease Exacerbation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diaphragm Electrical Activity
COPD (Chronic Obstructive Pulmonary Disease)
Keywords: chronic obstructive pulmonary disease exacerbation
Electrical diaphragmatic stimulation
Lead sponsor: Mansoura University Hospital
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Effect of trans-cutenuous electrical diaphragmatic stimulation on severe chronic obstructive pulmonary disease exacerbation
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome is the progression to invasive mechanical ventilation(IMV)
timeFrame: 6 months
Secondary outcomes:
measure: The secondary outcomes is the duration of ICU admission
timeFrame: 12 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of medicine mansoura university
Study officials:
affiliation: Lecturer of chest medicine faculty of medicine Mansoura university
name: Mohamed AbdElmoniem, lecturer
role: PRINCIPAL_INVESTIGATOR
References: