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Electric pulses to the diaphragm: a new way to avoid breathing tubes?

NCT ID NCT07020299

Disease control Sponsor: Mansoura University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This trial tests whether a non-invasive device that sends electrical pulses through the skin to stimulate the diaphragm can help people hospitalized with a severe COPD flare-up. The goal is to see if this technique improves diaphragm function and reduces the need for invasive mechanical ventilation. Adults with severe COPD exacerbations are eligible, while those with certain conditions like high BMI or unstable health are excluded. The study measures diaphragm movement and thickness, as well as ICU stay duration.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transcutaneous electrical diaphragmatic stimulation (TEDS) using a digital electrical muscle stimulator applied to the skin to induce diaphragm contractions
What this could lead to
If effective, this non-invasive technique could help severe COPD patients breathe better during flare-ups, potentially reducing the need for invasive mechanical ventilation and shortening ICU stays.
What could go wrong
This is an early-stage trial, and results may not confirm benefit. Risks include skin irritation from electrodes and the possibility that stimulation may not improve outcomes for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

128 people

The number who actually took part.

Started

Aug 2024

Finished

Aug 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease COPD, severe early onset

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COPD, chronic obstructive pulmonary disease Diaphragm electrical activity

Contacts and locations

Locations

  • Faculty of medicine mansoura university

    Al Mansurah, 35516, Egypt

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