Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06510972

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

Led by University Hospital, Tours · Updated on 2026-02-18

754

Participants Needed

14

Research Sites

160 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 years or older
  • Affiliated with a social security scheme
  • Provide oral consent, or consent from a trusted person or next of kin
  • Hospitalized in an intensive care or continuous surveillance unit for less than 24 hours
  • Diagnosed with acute hypoxaemic respiratory failure defined by respiratory rate over 25 breaths per minute or confirmed SARS-CoV-2 infection
  • Oxygenation status with PaO2/FiO2 less than 200 mmHg or SpO2/FiO2 less than 235 while on at least 10 L/min high concentration oxygen mask
Not Eligible

You will not qualify if you...

  • Need for immediate intubation due to worsening respiratory failure, acidosis, severe hypoxia, or other clinical signs
  • Major hemodynamic failure requiring increasing vasopressor support
  • Neurological failure with Glasgow coma score less than 8
  • Cardiac or respiratory arrest
  • Severe chronic lung disease (COPD GOLD grade 3 or 4) or other chronic lung diseases needing long-term oxygen or ventilation
  • Known swallowing difficulties or contraindications to oral nutrition
  • Presence of feeding tubes such as nasogastric, orogastric, jejunostomy, or feeding ileostomy
  • Already on invasive mechanical ventilation at admission
  • Decisions limiting therapy including no intubation orders
  • Legal incapacity (guardianship or curatorship)
  • Pregnant, in labor, or breastfeeding
  • Having a tracheostomy
  • Previously enrolled in this study

AI-Screening

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Trial Site Locations

Total: 14 locations

1

Intensive care, University Hospital, Blois

Blois, France

Not Yet Recruiting

2

Intensive care, Hospital, Bourges

Bourges, France

Actively Recruiting

3

Intensive care, Hospital, Colombes

Colombes, France

Actively Recruiting

4

Intensive care, Hospital, Dreux

Dreux, France

Actively Recruiting

5

Intensive care, Hospital, La Roche sur Yon

La Roche-sur-Yon, France

Actively Recruiting

6

Intensive care, Hospital, Le MANS

Le Mans, France

Actively Recruiting

7

Intensive care, Hospital, Lille

Lille, France

Actively Recruiting

8

Intensive care, Hospital, Morlaix

Morlaix, France

Actively Recruiting

9

Intensive care, Hospital, Nantes

Nantes, France

Actively Recruiting

10

Intensive care, University Hospital, Orléans

Orléans, France

Actively Recruiting

11

Intensive care, Hospital, poitiers

Poitiers, France

Actively Recruiting

12

Intensive care, Hospital, Saint Brieuc

Saint-Brieuc, France

Actively Recruiting

13

Intensive care, Hospital, Saint-Nazaire

Saint-Nazaire, France

Actively Recruiting

14

Intensive care, University Hospital, Tours

Tours, France

Actively Recruiting

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Research Team

P

Piotr SZYCHOWIAK, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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