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

Sponsor
University Hospital, Tours
Study ID
NCT06510972
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oral intake continuation strategy — PROCEDURE
    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 — PROCEDURE
    The patient will not be able to ingest liquids or solid food.

Study Details

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.

Key Dates

First listed
Jul 19, 2024
Start date
Feb 5, 2025
Status verified
Aug 2025
Primary completion
Feb 29, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
754 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.
  • 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.

Primary Outcome Measure

Percentage of patients intubated or dying without intubation within 96 hours of randomisation [ Time Frame: From randomisation to 96 hours ]

Central Contacts

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