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ICU fasting tradition questioned: new study tests if eating before intubation is safe

NCT ID NCT06510972

Knowledge-focused Sponsor: University Hospital, Tours 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether patients with severe breathing problems in the ICU should be allowed to eat or drink before they need a breathing tube. Currently, patients are often kept fasting to prevent food from entering the lungs, but this can cause discomfort and malnutrition. The study will compare two groups: one that continues eating and one that fasts, to see if eating increases the risk of needing a tube or dying within 96 hours. About 754 adults in intensive care will take part.

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 754 people

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

Started

Feb 2025

Expected to finish

Mar 2028

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: * Male or female ≥ 18 years old * Participant affiliated to a social security scheme * Express oral consent of the participant, or failing that of the trusted support person, or failing that of the next of kin * Patient hospitalised in an intensive care unit or in a continuous surveillance unit or in an intensive care unit for less than 24 hours. * Criteria for acute hypoxaemic respiratory failure defined as. * Respiratory rate \> 25 cpm or indifferent if SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) infection occurred ≥ 1 time since admission. * PaO2/FiO2 \< 200 mmHg or equivalent SpO2 (oxygen saturation)/FiO2 (fraction of inspired oxygen) i.e. \< 235 (measured under at least 10 L/min high concentration mask) Exclusion Criteria: * Patient with criteria for immediate intubation: * Persistent or worsening respiratory failure (respiratory rate \> 40/min, respiratory failure on physical examination, respiratory acidosis with pH (hydrogen potential ) \< 7.25, copious tracheal secretions, hypoxia with SpO2 \< 90% despite FiO2 \> 80% for more than 5 minutes without technical dysfunction). * Major haemodynamic failure (need for increasing vasopressor support with instability and hypoperfusion). * Neurological failure (Glasgow score \< 8). * Cardiac or respiratory arrest * Chronic lung disease: chronic obstructive pulmonary disease (GOLD grade 3 or 4: Global Initiative for Chronic Obstructive Lung Disease) or other chronic lung disease requiring long-term oxygen or ventilation (this does not include a patient undergoing continuous positive nocturnal pressure for sleep apnoea syndrome). * Contraindications to oral nutrition: known previous swallowing problems or inability to swallow, digestive sutures, admission for inhalation pneumonia, exclusive parenteral nutrition, etc. * Patients with a nasogastric or orogastric tube, a jejunostomy or a feeding ileostomy * Patient already on invasive mechanical ventilation on admission * Limitation of therapies including a decision not to intubate * Incapacitated adult (guardianship or curators) * Pregnant, parturient or breast-feeding women * Tracheostomised patient * Patient already included for the first time in this study

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Conditions

The condition(s) this trial relates to.

acute respiratory failure Deglutition Disorders Fasting respiratory failure

As listed by the trial registrant

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

Aspiration Dysphagia Fasting Respiratory insufficiency Swallowing disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 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

  • Intensive care, Hospital, Bourges

    RECRUITING

    Bourges, France

  • Intensive care, Hospital, Colombes

    RECRUITING

    Colombes, France

  • Intensive care, Hospital, Dreux

    RECRUITING

    Dreux, France

  • Intensive care, Hospital, La Roche sur Yon

    RECRUITING

    La Roche-sur-Yon, France

  • Intensive care, Hospital, Le MANS

    RECRUITING

    Le Mans, France

  • Intensive care, Hospital, Lille

    RECRUITING

    Lille, France

  • Intensive care, Hospital, Morlaix

    RECRUITING

    Morlaix, France

  • Intensive care, Hospital, Nantes

    RECRUITING

    Nantes, France

  • Intensive care, Hospital, Saint Brieuc

    RECRUITING

    Saint-Brieuc, France

  • Intensive care, Hospital, Saint-Nazaire

    RECRUITING

    Saint-Nazaire, France

  • Intensive care, Hospital, poitiers

    RECRUITING

    Poitiers, France

  • Intensive care, University Hospital, Blois

    NOT_YET_RECRUITING

    Blois, France

  • Intensive care, University Hospital, Orléans

    RECRUITING

    Orléans, France

  • Intensive care, University Hospital, Tours

    RECRUITING

    Tours, France

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