Could skipping a breathing test speed up ventilator removal?
NCT ID NCT07019636
First seen Jul 17, 2026 · Last updated Jul 17, 2026
Summary
This study tests whether patients who are ready to come off a breathing machine can be safely extubated right away, without first doing a spontaneous breathing trial. It includes adults aged 18–65 who have been on a ventilator for 1–4 days and are considered low risk for extubation failure. The main goal is to see if direct extubation leads to more patients staying off the ventilator for at least 72 hours compared to the standard approach of a breathing test first.
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 simplify weaning protocols for low-risk patients, reducing time on ventilators and hospital stays.
- What could go wrong
- This is a single, open-label trial with 314 participants, so results may not apply broadly. Direct extubation could increase the risk of breathing failure or need for reintubation.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 314 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 older than 18 years and \< 65 years old * Nasal or oral intubation longer than 24 hours and less than 4 days * Satisfaction to each following weaning readiness criteria: 1. Respiratory rate \< 35 cycles per minute 2. SpO2 \>90% with FiO2\<40% and PEEP\<8 cmH2O 3. RASS score between -2 and +2 with low level or no sedatives 4. No need or low doses of vasopressors 5. Adequate cough * Inform consent by patient or legal representative or the close relative or emergency inclusion procedure. Exclusion Criteria: * Risk factor for extubation failure as defined by any of the following criteria: * Chronic cardiac disease (left ejection fraction below 45%, documented history of cardiogenic pulmonary edema, permanent atrial fibrillation). * Chronic respiratory disease (severe COPD, documented restricted lung disease or obesity-hypoventilation syndrome) * Body mass index \> 30 kg/m2 * Airway patency problems, including high risk of developing laryngeal edema, inability to deal with respiratory secretions, brain injury, documented swallowing disorders * Tracheostomy * Underlying chronic neuromuscular disease * Do not resuscitate orders * Pregnant or lacting woman * Patient under guardianship * Patient without healthcare insurance * Refusal to participate and sign the written consent * Patients with traumatic brain injury * Post surgery patients * Patients included in another interventional trial that may have an impact on the evaluation criteria of the present study * Patient under AME
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Hôpital Pitié Salpêtrière
RECRUITINGParis, 75013, France
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