Skip to content

Effect of Electrical Diaphragmatic Stimulation on Chronic Obstructive Pulmonary Disease

Effect of Trans-cutenuous Electrical Diaphragmatic Stimulation on Severe Chronic Obstructive Pulmonary Disease Exacerbation

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07020299
Enrollment
128
Registered
2025-06-13
Start date
2024-08-01
Completion date
2026-08-01
Last updated
2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD (Chronic Obstructive Pulmonary Disease), Diaphragm Electrical Activity

Keywords

chronic obstructive pulmonary disease exacerbation, Electrical diaphragmatic stimulation

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

Interventions

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

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.

Sponsors

Mansoura University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The primary outcome is the progression to invasive mechanical ventilation(IMV)6 monthsFunctional 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

MeasureTime frameDescription
The secondary outcomes is the duration of ICU admission12 monthsThe secondary outcomes is the duration of ICU admission (days), the immediate effect of TEDS and after sessions.

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORMohamed AbdElmoniem, lecturer

Lecturer of chest medicine faculty of medicine Mansoura university

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026