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Active, Not Recruiting

NCT Number: NCT07020299

Effect of Electrical Diaphragmatic Stimulation on Chronic Obstructive Pulmonary Disease

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine mansoura university

Al Mansurah, 35516, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. The secondary outcomes is the duration of ICU admission

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Mansoura University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 13, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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