ClinicalTrials.gg
RecruitingNCT06510972JEUN-TUBEUpdated Feb 18, 2026

Non-inferiority of Continuing Oral Intake Versus Fasting in Patients With Acute Respiratory Failure

An interventional study of Oral intake continuation strategy and Fasting strategy in Respiratory Insufficiency, Fasting and Dysphagia, sponsored by University Hospital, Tours. Recruiting at 14 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-18.

Sponsored by University Hospital, Tours · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
754
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Fasting in intensive care is mainly studied in mechanically ventilated patients or those in the weaning phase. Recent research challenge the common assumption of fasting and suggests that continuing enteral nutrition before extubation may be beneficial. Fasting is also practiced before procedures (e.g., tracheostomy, endoscopy) or surgeries, based on anesthetic guidelines. Yet, no data address fasting in non-intubated ICU patients with acute respiratory failure, despite frequent caloric deficits and inadequate nutritional intake.

Aspiration risk often justifies fasting, but studies indicate that swallowing reflexes remain intact in patients receiving high-flow nasal oxygen or non-invasive ventilation. Moreover, although intubation carries a 2-5.9% aspiration risk, rapid sequence induction mitigates this, questioning the necessity of preventive fasting. Despite its prevalence, this practice lacks scientific validation and guideline support.

Patient discomfort is also significant. Hunger and thirst are major sources of distress, and evidence from anesthesiology suggests that allowing fluid intake pre-anesthesia reduces discomfort. Extrapolating these findings to ICU patients could improve well-being.

In conclusion, fasting in ICU patients may contribute to discomfort, dehydration, and malnutrition, while its protective benefits remain uncertain. We hypothesize that maintaining oral intake does not increase the risk of intubation or aspiration-related complications.

Read the detailed description

Fasting in intensive care is a crucial issue that has primarily been studied in mechanically ventilated patients or during the mechanical ventilation weaning process. This practice has recently been challenged with a study which demonstrated the benefits of continuing enteral nutrition before extubation compared to maintaining an empty stomach. Fasting has also been studied in the context of technical procedures (such as tracheostomy or endoscopy) and before surgery, based on an analogy with pre-anesthetic fasting recommendations.

To our knowledge, no data are available regarding fasting in critically ill patients with acute respiratory failure who are hospitalized in the ICU but not intubated. Nutritional management in this specific patient population is not addressed in current ICU nutrition guidelines, despite evidence in the literature showing that these patients frequently fail to meet theoretical caloric targets. A large proportion of them receive no nutritional intake, whether orally, enterally via a nasogastric or orogastric tube, or parenterally. This highlights a strong rationale for maintaining nutritional support in patients with acute respiratory failure.

One of the major concerns among healthcare teams managing these patients is the potential risk of aspiration. This often leads to delays in resuming oral intake, with patients remaining fasting, possibly as an overly cautious approach. However, several experimental studies, including animal models and studies in patients with acute respiratory failure receiving respiratory support (such as high-flow nasal oxygen therapy or non-invasive ventilation), suggest that swallowing reflexes remain intact in these situations.

Beyond aspiration concerns, tracheal intubation in ICU patients requiring mechanical ventilation carries a risk of gastric content aspiration, estimated between 2% and 5.9% in different studies, potentially leading to pneumonia. Clinically, aspiration may be asymptomatic but can also result in severe pneumonia, acute respiratory distress syndrome, pulmonary fibrosis, and, ultimately, life-threatening complications.

During anesthesia for scheduled surgery, controlled operating room conditions allow for preoperative fasting (six hours without solid food and two hours without clear liquids) before anesthetic induction. By analogy, in intensive care, patients at risk of intubation are often kept fasting as a preventive measure to reduce the risk of aspiration and potential gastric content inhalation in the event of intubation. However, this common practice in ICUs remains unstudied in the literature and is not included in clinical guidelines. Moreover, the systematic use of rapid sequence induction techniques during emergency intubation minimizes the risk of aspiration, potentially reducing the need for preemptive fasting.

Finally, ICU patients experience multiple discomforts. Several studies, including a French study validating the IPREA score, have identified hunger and, more notably, thirst as major sources of discomfort in the ICU. In anesthesiology, preoperative comfort has been extensively studied, and research has shown that allowing patients to drink before general anesthesia significantly reduces thirst and hunger sensations. It is reasonable to extrapolate these findings to ICU patients with acute respiratory failure, suggesting that permitting the intake of liquids and solid foods could improve their overall comfort.

Thus, fasting in the ICU may be potentially harmful - hunger and thirst are frequent sources of discomfort, and dehydration and malnutrition are often inadequately compensated by parenteral routes - while its benefits remain uncertain.

We hypothesize that continuing oral intake in ICU patients at risk of intubation does not increase the need for intubation and does not lead to higher rates of adverse events, such as aspiration or gastric content inhalation, in patients who ultimately require intubation.

02

Conditions studied

  • Respiratory Insufficiency
  • Fasting
  • Dysphagia
  • Swallowing Disorder
  • Aspiration

Keywords

  • acute respiratory failure
  • fasting
  • oral intake
  • aspiration
  • intubation
  • high-flow nasal oxygen
03

In context

Respiratory Insufficiency

1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.

This study's planned enrollment of 754 is above the median of 60 across 860 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

University Hospital, Tours is the lead sponsor of 307 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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: (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).
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
754 participants (estimated)

Study arms

  • Experimental
    Oral intake continuation strategy

    The patient will be allowed to ingest liquids or solid foods orally, of any type, at an unrestricted frequency and quantity, according to their tolerance, with nurse assistance if necessary. Essential treatments will be administered orally when applicable. The patient will receive regular oral care. Both oral and intravenous intake will be quantified. The physician in charge must ensure that the patient receives a minimal caloric intake, either through intravenous glucose supplementation or parenteral nutrition, with the quantity left to the physician's discretion.

    Procedure: Oral intake continuation strategy

  • Active comparator
    Fasting strategy

    The patient will not be allowed to ingest any liquids or solid foods. The patient will receive regular oral care. Essential oral medications, if no parenteral alternative is available, may be administered under nurse supervision (maximum daily water intake: 100 mL). The physician in charge must ensure that the patient receives a minimal caloric intake through intravenous glucose supplementation or parenteral nutrition, with the quantity left to the physician's discretion.

    Procedure: Fasting strategy

Interventions

  • ProcedureOral intake continuation strategy

    The patient will be allowed to ingest liquids or solid foods orally, of any type, at an unrestricted frequency and quantity, according to their tolerance.

  • ProcedureFasting strategy

    The patient will not be able to ingest liquids or solid food.

06

What researchers measure

Primary outcomes

  1. Percentage of patients intubated or dying without intubation within 96 hours of randomisation

    Time frame: From randomisation to 96 hours

Secondary outcomes

  1. Simple verbal scale between 1 and 4 of sensation of thirst and hunger at D1 after randomisation

    Time frame: At Day 1 after randomisation

  2. Mortality at D28

    Time frame: At Day 28

  3. Time from randomisation to intubation to Day 28

    Time frame: From randomisation to day 28

  4. Occurrence of vomiting during intubation

    Time frame: Between the start and end of the intubation procedure

  5. Immediate post-intubation salivary amylase and pepsin rates

    Time frame: Immediate post-intubation

  6. Natraemia rates within 4 days of randomisation

    Time frame: From randomisation to day 4

  7. Occurrence of acute renal failure within 4 days of randomisation

    Time frame: From randomisation to day 4

  8. Occurrence of hypoglycaemia within 4 days of randomisation

    Time frame: From randomisation to day 4

  9. Occurrence of at least one nosocomial pneumonia within 28 days of randomisation

    Time frame: From randomisation to day 28

  10. Occurrence of at least one pneumonia acquired under early mechanical ventilation

    Time frame: From randomisation to day 28

07

Study locations

13 of 14 sites recruiting
  • Intensive care, University Hospital, Blois
    Blois, France
    Not yet recruiting
    • Julien GROUILLE, MD · Contact
    • Julien GROUILLE, MD · Principal investigator
  • Intensive care, Hospital, Bourges
    Bourges, France
    Recruiting
    • Anna BOURREAU, MD · Contact
    • Anna BOURREAU · Principal investigator
  • Intensive care, Hospital, Colombes
    Colombes, France
    Recruiting
    • Damien ROUX, MCU-PH · Contact
    • Damien ROUX · Principal investigator
  • Intensive care, Hospital, Dreux
    Dreux, France
    Recruiting
    • Thomas JANSON, MD · Contact
    • Thomas JANSON · Principal investigator
  • Intensive care, Hospital, La Roche sur Yon
    La Roche-sur-Yon, France
    Recruiting
    • Laureen GUILLEMIN, MD · Contact
    • Laureen GUILLEMIN, MD · Principal investigator
  • Intensive care, Hospital, Le MANS
    Le Mans, France
    Recruiting
    • Mickael LANDAIS, MD · Contact
    • Mickael LANDAIS · Principal investigator
  • Intensive care, Hospital, Lille
    Lille, France
    Recruiting
    • Saadalla NSEIR, MD · Contact
    • Saadalla NSEIR · Principal investigator
  • Intensive care, Hospital, Morlaix
    Morlaix, France
    Recruiting
    • Pierre-Yves EGRETEAU, MD · Contact
    • Pierre-Yves EGRETEAU · Principal investigator
  • Intensive care, Hospital, Nantes
    Nantes, France
    Recruiting
    • Jean REIGNIER, MCU-PH · Contact
    • Jean REIGNIER · Principal investigator
  • Intensive care, University Hospital, Orléans
    Orléans, France
    Recruiting
    • Piotr SZYCHOWIAK, MD · Contact
    • Piotr SZYCHOWIAK · Principal investigator
  • Intensive care, Hospital, poitiers
    Poitiers, France
    Recruiting
    • Sylvain LE PAPE, MD · Contact
    • Sylvain LE PAPE · Principal investigator
  • Intensive care, Hospital, Saint Brieuc
    Saint-Brieuc, France
    Recruiting
    • Nicolas MASSART, MD · Contact
    • Nicolas MASSART · Principal investigator
  • Intensive care, Hospital, Saint-Nazaire
    Saint-Nazaire, France
    Recruiting
    • Patricia COUROUBLE, MD · Contact
    • Patricia COUROUBLE · Principal investigator
  • Intensive care, University Hospital, Tours
    Tours, France
    Recruiting
    • Stephan EHRMANN · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2025 (actual). Primary completion is estimated for Feb 2028, 36 months after the start.

Of 359 non-industry interventional studies with no phase under Respiratory Insufficiency, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's planned 36 months is above that.

Counting every sponsor, half of 375 studies reached it within 24 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 9, 2024
First posted
Jul 19, 2024
StartActual
Feb 5, 2025
Primary completionEst.
Feb 2028
CompletionEst.
Mar 2028
Last update
Feb 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06510972
Responsible party
Sponsor
First posted
Jul 19, 2024
Start date
Feb 5, 2025
Primary completion
Feb 2028 (estimated)
Completion
Mar 2028 (estimated)
Last update
Feb 18, 2026

Study contacts

Piotr SZYCHOWIAK, MD
Contact
piotr.szychowiak@gmail.com
2.38.22.95.58 ext. +33
Piotr SZYCHOWIAK, MD
study director · University Hospital, Orléans

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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