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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Tours

About this trial

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 criteria

Qualifiers

Male or female ≥ 18 years old

Participant affiliated to a social security scheme

Express oral consent of the participant, or failing that of the trusted support person, or failing that of the next of kin

Patient hospitalised in an intensive care unit or in a continuous surveillance unit or in an intensive care unit for less than 24 hours.

Disqualifiers

Persistent or worsening respiratory failure (respiratory rate > 40/min, respiratory failure on physical examination, respiratory acidosis with pH (hydrogen potential ) < 7.25, copious tracheal secretions, hypoxia with SpO2 < 90% despite FiO2 > 80% for more than 5 minutes without technical dysfunction).

Major haemodynamic failure (need for increasing vasopressor support with instability and hypoperfusion).

Neurological failure (Glasgow score < 8).

Cardiac or respiratory arrest

Trial design

Treatments tested in this trial

  • Oral intake continuation strategy
  • Fasting strategy

Treatment groups

754 Participants
are divided into 2 treatment groups

Sponsors and collaborators