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

NCT06510972 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 754

Last updated 2026-02-18

No results posted yet for this 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.

Conditions

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

Interventions

PROCEDURE

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.

PROCEDURE

Fasting strategy

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

Sponsors & Collaborators

  • University Hospital, Tours

    lead OTHER

Principal Investigators

  • Piotr SZYCHOWIAK, MD · University Hospital, Orléans

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-05
Primary Completion
2028-02-29
Completion
2028-03-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06510972 on ClinicalTrials.gov