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New oxygen device may help breathing patients between treatments

NCT ID NCT02389166

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether a high-flow oxygen system (Optiflow) works better than a standard oxygen mask for patients with breathing failure. About 100 adults in intensive care who needed non-invasive ventilation (NIV) took part. The goal was to see if Optiflow keeps oxygen levels more stable between NIV sessions.

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

95 people

The number who actually took part.

Started

Jun 2015

Finished

Mar 2019

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 at least 18 years old * Patients affiliated to or benefiting of the French social welfare system * Patients with ARDS on previously healthy lung. Acute respiratory insufficiency, defined as the PaO2/FIO2 ratio less than 200 mm Hg associated with the presence of lung infiltrates on chest radiograph * Free and informed consent of patient * Hospitalized in one of involved ICU Exclusion Criteria: * Existence of criteria for intubation. * Refusal to participate in the study. * Pregnancy * Patient under guardianship or trusteeship * Patients for whom a decision of non intubation has been decided. * Patients who have received one or several NIV session for ARDS before hospital admission * Home noninvasive ventilation * Tracheostomy * Hemodynamic instability * Hypercapnia (PaCO2\>45 mm Hg). * left ventricular failure (cardiogenic pulmonary acute edema). * Ineffective coughing. * Recent gastric or oesophageal surgery * Severe ventricular rhythm disorder * High digestive haemorrhage * Lack of collaboration * Pernicious vomiting * Upper airway obstruction * Severe sepsis. * Undrained pneumothorax.

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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.

Contacts and locations

Locations

  • Réanimation Polyvalente - CH de Mont de Marsan

    Mont-de-Marsan, 40024, France

  • Réanimation polyvalente - CH d'Albi

    Albi, 81000, France

  • Service de Réanimation - CH de Perigueux

    Périgueux, Aquitiane, 24000, France

  • Service de Réanimation Polyvalente - CH d'Agen

    Agen, 47923, France

  • Service de Réanimation Polyvalente - CH de Libourne

    Libourne, Aquitaine, 33505, France

  • Service de Réanimation Polyvalente - CHU de Toulouse

    Toulouse, Midi-pyrenees, 31059, France

  • Service de réanimation - CH de la côte basque

    Bayonne, Aquitaine, 64100, France

  • Service de réanimation médicale - CHU de Bordeaux

    Bordeaux, Aquitaine, 33000, France

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