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New breathing therapy aims to cut ventilator dependence in ICU patients

NCT ID NCT06499389

Symptom relief Sponsor: Hospices Civils de Lyon 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether early, intensive respiratory physiotherapy can improve cough strength in ICU patients with muscle weakness who are struggling to come off a ventilator. Fifty adults on breathing machines will receive either three daily sessions of specialized breathing exercises or standard care. The goal is to see if the extra therapy helps them breathe on their own more successfully.

What this could mean

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

Active substance
respiratory physiotherapy (intensive, instrumental, early)
What this could lead to
If successful, this approach could help ICU patients with muscle weakness breathe on their own sooner and reduce the risk of needing a breathing tube again.
What could go wrong
This is a small, early-stage trial with only 50 participants, so results may not apply to all patients. The intensive therapy may be tiring or uncomfortable for some.

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 50 people

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

Started

Mar 2025

Expected to finish

May 2027

An estimate. End dates often move.

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: * Patient 18 years or more, affiliated to a social security system * Patients on invasive mechanical ventilation for 48 hours or more * Failure of at least one mechanical ventilation weaning test (spontaneous breathing trial, SBT) * First successful SBT on the day of eligibility assessment * Medical Research Council (MRC) score \< 48 and/or cough strength ≤ 2 on the 6-point Likert scale Exclusion Criteria: * Recent brain injury (\< 3 months, stroke, cardiopulmonary arrest) * Delirium tremens (Cushman score \> 7) * Chronic neuromuscular pathology * Patient under continuous intravenous sedation * Patient unresponsive to simple commands and Richmond Agitation and Sedation Scale (RASS) score \< -2 or \> +1 * FiO2: Inspired Oxygen Fraction\> 50%, percutaneous, O2: oxygen saturation \< 88%, positive end-expiratory pressure \> 5 centimeter of water (cmH2O) or respiratory rate ≥ 35 min-1 * Vasopressor catecholamine at a dose \> 0.5 μg/kg/min * Tracheostomized patient * Undrained pneumothorax * Pulmonary emphysema (identified as antecedent in medical record) * Uncontrolled hemoptysis * Surgery \< 3 months of esophagus and/or the ear, nose and throat (ENT) sphere * Pregnancy or lactating * Patient deprived of liberty by judicial or administrative decision * Patient under guardianship or curatorship * Patient already included in the same study or in another study sharing the same primary endpoint

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Conditions

The condition(s) this trial relates to.

critical illness polyneuropathy

As listed by the trial registrant

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

Ventilator weaning

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

  • Département d'Anesthésie Réanimation - Médecine Intensive, Centre Hospitalier Lyon Sud

    RECRUITING

    Lyon, 69495, France

  • Médecine Intensive - Réanimation, Hôpital de la Croix Rousse

    RECRUITING

    Lyon, 69004, France

  • Service d'Anesthésie et Réanimation, Hôpital de la Croix Rousse, GHN

    NOT_YET_RECRUITING

    Lyon, France, 69004, France

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