Effect of Electrical Diaphragmatic Stimulation on Chronic Obstructive Pulmonary Disease

NCT07020299 | Active Not Recruiting

• 1 other identifier: MD.24.08.878
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Diaphragm Electrical Activity; COPD (Chronic Obstructive Pulmonary Disease)

Keywords

chronic obstructive pulmonary disease exacerbation; Electrical diaphragmatic stimulation

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the progression to invasive mechanical ventilation(IMV)

  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).

  6 months

Secondary Outcomes (1)

• The secondary outcomes is the duration of ICU admission

  12 months

Study Arms (2)

TEDS group will be subjected to sessions of TEDS

ACTIVE COMPARATOR

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.

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

Non TEDS group will not be subjected to sessions of TEDS

Interventions

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

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.

TEDS group will be subjected to sessions of TEDS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University Hospital: lead

Study Sites (1)

Faculty of medicine mansoura university

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohamed AbdElmoniem, lecturer

  Lecturer of chest medicine faculty of medicine Mansoura university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Participants will be randomly assigned into a TEDS group or control group. Method of randomization : Before participant recruitment, sequential sealed envelopes are prepared by an independent investigator, with one envelope will be chosen randomly by another investigator for each participant.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of chest medicine department faculty of medicine mansoura university

Model Details: Effect of trans-cutenuous electrical diaphragmatic stimulation on severe chronic obstructive pulmonary disease exacerbation

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 13, 2025
• Study Start: August 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)