RecruitingNot ApplicableNCT06510972

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

Continuation of Oral Intake Compared With Fasting in Patients With Acute Respiratory Failure Before Intubation : a Non-inferiority Randomized Clinical Trial


Sponsor

University Hospital, Tours

Enrollment

754 participants

Start Date

Feb 5, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Fasting strategy and a procedure called Oral intake continuation strategy for people with aspiration, dysphagia, and other related conditions. The study is currently recruiting participants at 14 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


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

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NCT06510972


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