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Non-inferiority of Continuing Oral Intake Versus Fasting in Patients With Acute Respiratory Failure
Sponsor: University Hospital, Tours
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.
Official title: Continuation of Oral Intake Compared With Fasting in Patients With Acute Respiratory Failure Before Intubation : a Non-inferiority Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
754
Start Date
2025-02-05
Completion Date
2028-03
Last Updated
2026-02-18
Healthy Volunteers
No
Interventions
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.
Fasting strategy
The patient will not be able to ingest liquids or solid food.
Locations (14)
Intensive care, University Hospital, Blois
Blois, France
Intensive care, Hospital, Bourges
Bourges, France
Intensive care, Hospital, Colombes
Colombes, France
Intensive care, Hospital, Dreux
Dreux, France
Intensive care, Hospital, La Roche sur Yon
La Roche-sur-Yon, France
Intensive care, Hospital, Le MANS
Le Mans, France
Intensive care, Hospital, Lille
Lille, France
Intensive care, Hospital, Morlaix
Morlaix, France
Intensive care, Hospital, Nantes
Nantes, France
Intensive care, University Hospital, Orléans
Orléans, France
Intensive care, Hospital, poitiers
Poitiers, France
Intensive care, Hospital, Saint Brieuc
Saint-Brieuc, France
Intensive care, Hospital, Saint-Nazaire
Saint-Nazaire, France
Intensive care, University Hospital, Tours
Tours, France