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Could a spirometer test guide breathing support in respiratory failure?

NCT ID NCT07750717

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This study looks at whether the amount of air a person breathes in on their own matches the amount they breathe when using a non-invasive ventilation (NIV) mask. It involves 30 adults with acute respiratory failure who are in intensive care. Researchers will measure tidal volume (breath size) during spontaneous breathing with a handheld spirometer and then during NIV with optimized settings. The goal is to see if a simple test can help predict how patients will respond to NIV, potentially aiding in personalized treatment decisions.

What this could mean

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

Active substance
Hand-held spirometer and non-invasive ventilation (NIV)
What this could lead to
If a link is found, doctors might use simple breathing tests to predict which patients will benefit from non-invasive ventilation, potentially improving care for acute respiratory failure.
What could go wrong
This is a small pilot study, so results may not apply broadly. The measurements might not correlate as expected, and the study does not test a treatment's effectiveness.

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 30 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 2029

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 over 18 years of age; * Patient hospitalized in intensive care for less than 24 hours; * Patient with severe hypoxemic acute respiratory failure characterized by a PaO2/FiO2 ratio \< 300 mmHg and \> 150 mmHg under high-flow oxygen therapy at 60 L/min; * Patient able to cooperate with the spirometry test; * Patient able to follow the protocol and having given their informed written consent to participate in the study; * Patient affiliated with the social security system or entitled to benefits; Exclusion Criteria: * Patients with an indication for intubation; * Patients with a contraindication for or who refuse NIV; * Patients with hemodynamic instability requiring vasopressor support greater than 0.25 μg/kg/min of norepinephrine; * Patients with a Glasgow score \< 15; * Patients with hypercapnia (PaCO2 \> 45 mmHg); * Patients with a PaO2/FiO2 ratio \< 150 mmHg; * Patients with cardiogenic pulmonary edema; * Patients who have already undergone a session of NIV in intensive care during this stay; * Patients with chronic respiratory failure (home oxygen therapy or home non-invasive ventilation (excluding indications solely for sleep apnea syndrome)); * Patients who have recently had a pneumothorax; * Patients who have recently undergone eye surgery (e.g., cataract surgery) or throat surgery; * Patients with significant arterial disease: recent heart attack, pulmonary embolism, poorly controlled hypertension despite treatment, etc. * Patients already included in the study; * Pregnant women, women in labor, or women who are breastfeeding; * Patients under guardianship, conservatorship, or deprived of their liberty; * Patients under an activated future protection mandate; * Patients under family authorization; * Patients under judicial protection;

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Conditions

The condition(s) this trial relates to.

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.

  1. The places running it

    1 site. 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

  • Centre Hospitalier Universitaire de Nantes - Hôpital Hôtel Dieu

    Nantes, 44093, France

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