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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Oral intake continuation strategy
Procedure/SurgeryThe 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/SurgeryThe patient will not be able to ingest liquids or solid food.
Treatment groups
754 Participants
are divided into 2 treatment groupsGroup A: Oral intake continuation strategyExperimental treatment 1 intervention
Group B: Fasting strategyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of patients intubated or dying without intubation within 96 hours of randomisation
Time frame
From randomisation to 96 hoursSecondary outcomes
1
Simple verbal scale between 1 and 4 of sensation of thirst and hunger at D1 after randomisation
Time frame
At Day 1 after randomisation2
Mortality at D28
Time frame
At Day 283
Time from randomisation to intubation to Day 28
Time frame
From randomisation to day 284
Occurrence of vomiting during intubation
Time frame
Between the start and end of the intubation procedureSponsors and contacts
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Source ClinicalTrials.gov