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New device aims to prevent Ventilator-Induced muscle weakness

NCT ID NCT07363902

Symptom relief Sponsor: Tesai Care SL Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new device called Heecap that uses gentle electrical stimulation to keep the breathing muscles active in ICU patients on mechanical ventilators. Many patients on ventilators develop weak breathing muscles, which can make it hard to breathe on their own later. The study will include 20 adults in the ICU to see if the device is safe and can correctly time the stimulation with the patient's own breathing.

What this could mean

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

Active substance
Heecap device (transcutaneous electrical stimulation of respiratory muscles)
What this could lead to
If it works, this could help ICU patients on ventilators keep their breathing muscles strong, potentially reducing time on the ventilator and speeding recovery.
What could go wrong
This is a very early, small safety study with only 20 participants. The device may not work as hoped, and there is a risk of discomfort or adverse events from electrical stimulation.

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

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: Patient population 1 * Adult patients with acute hypoxemic respiratory failure who have been under controlled mechanical ventilation for at least 24 hours prior to enrollment. * Clinically stable: oxygen saturation \> 90% with a fractional inspired oxygen ≤ 0.50, eternal PEEP ≤ 10 cm H2O, temperature ranging from 35.5 to 38.5 ºC, no intravenous administration of vasoactive agents. Patient population 2 * Adult patients with acute hypoxemic respiratory failure who have been under pressure support mechanical ventilation for at least 24 hours prior to enrollment. * Clinically stable: oxygen saturation \> 90% with a fractional inspired oxygen ≤ 0.50, eternal PEEP ≤ 10 cm H2O, temperature ranging from 35.5 to 38.5 ºC, no intravenous administration of vasoactive agents. Exclusion Criteria: * Patients treated with neuromuscular blocking agents * Patients with neuromuscular disease * Patients with a pacemaker or past history of arrhythmia * Patients with physical obstacles that prevent thoracic or abdominal electrostimulation (e.g., abdominal trauma, recent abdominal surgery, polytrauma, broken or irritated skin) * BMI \> 40 kg/m2 * Hemodynamically unstable (noradrenaline \>0.1 microgram/kg/min) * Pregnancy * Patients under the age of 18 * The formalized ethical decision to withhold or withdraw life support * Patient under guardianship * Patients deprived of liberties * Patients already enrolled in the present study, in a previous episode of acute respiratory failure. * The patient who does not consent.

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Conditions

The condition(s) this trial relates to.

acute respiratory failure

As listed by the trial registrant

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

Ventilator induced diaphragm dysfunction VIDD Weaning failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Universitari Parc Tauli

    RECRUITING

    Sabadell, Barcelona, 08208, Spain

  • Hospital Universitari de Bellvitge

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Hospital Universitari de Vall d'Hebrón

    RECRUITING

    Barcelona, Barcelona, 08035, Spain

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