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Breathing trial showdown: which method helps ICU patients breathe on their own?

NCT ID NCT04222569

Knowledge-focused Sponsor: University Hospital, Montpellier 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 looked at three different breathing tests (spontaneous breathing trials) used to see if ICU patients are ready to have their breathing tube removed. Researchers measured how hard patients had to work to breathe during each test. The goal was to find which test works best for different types of patients. The study was stopped early, so the results are not complete.

What this could mean

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

What this could lead to
If successful, this could help doctors choose the best breathing test for each patient, making it easier and safer to remove breathing tubes.
What could go wrong
The study was terminated early, so results are limited. It was also small and focused on specific patient profiles, so findings may not apply to everyone.

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

117 people

The number who actually took part.

Started

Jun 2020

Finished

Jun 2023

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: * ICU patient with invasive mechanical ventilation for at least 24 hours * Physician decision to extubate and all criteria for ventilatory weaning must be present * Resolution of disease acute phase for which the patient was intubated * Conscious patient (Richmond Agitation-Sedation Scale (RASS) \> 0), no sedation * Good coughing effort, good swallowing, positive leak test (\> 12% of tidal volume (VT)) * No important secretions * No respiratory acidosis, adequate oxygenation (PaO2 / FiO2 \> 150 mmHg and CPAP ≤ 8) * Adequate pulmonary function (respiratory rate (RR) ≤ 35, negative inspiratory force (NIF) \> 20 cmH2O, RR/VT \< 105) * Stable cardiovascular status (heart rate (HR) \< 140 bpm, systolic blood pressure \> 90 mmHg, no or minimal vasopressors) * If severe brain injury, the VISAGE score must be ≥ 3 (visual pursuit, good swallowing, GCS \> 10) Exclusion Criteria: * Obese patients with BMI ≥ 35 kg/m2 * Contraindication for nasogastric tube or esophageal manometric balloon placement * Refusal of study participation or to pursue the study by the patient, no consent * Pregnancy or breastfeeding * Absence of coverage by the French statutory healthcare insurance system

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As listed by the trial registrant

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

Intensive care unit Invasive mechanical ventilation Ready to wean from ventilation

Contacts and locations

Locations

  • Centre Hospitalier Universitaire Saint Eloi

    Montpellier, Herault, 34000, France

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