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

Recruiting now · Not applicable

Conditions studied: Respiratory Insufficiency, Fasting, Dysphagia, Swallowing Disorder, Aspiration

In brief

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 facts

Study ID

NCT06510972

Run by

University Hospital, Tours

People needed

754

Starts

2025-02-05

Expected to finish

2028-03-01

Last updated by the study team

2026-02-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Criteria for acute hypoxaemic respiratory failure defined as.
• Respiratory rate > 25 cpm or indifferent if SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) infection occurred ≥ 1 time since admission.
• PaO2/FiO2 < 200 mmHg or equivalent SpO2 (oxygen saturation)/FiO2 (fraction of inspired oxygen) i.e. < 235 (measured under at least 10 L/min high concentration mask)

You may not qualify if…

• Patient with criteria for immediate intubation:
• 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
• Chronic lung disease: chronic obstructive pulmonary disease (GOLD grade 3 or 4: Global Initiative for Chronic Obstructive Lung Disease) or other chronic lung disease requiring long-term oxygen or ventilation (this does not include a patient undergoing continuous positive nocturnal pressure for sleep apnoea syndrome).
• Contraindications to oral nutrition: known previous swallowing problems or inability to swallow, digestive sutures, admission for inhalation pneumonia, exclusive parenteral nutrition, etc.
• Patients with a nasogastric or orogastric tube, a jejunostomy or a feeding ileostomy
• Patient already on invasive mechanical ventilation on admission
• Limitation of therapies including a decision not to intubate
• Incapacitated adult (guardianship or curators)
• Pregnant, parturient or breast-feeding women
• Tracheostomised patient
• Patient already included for the first time in this study

Where it is running

• Intensive care, University Hospital, Tours — Tours, France (enrolling)
• Intensive care, Hospital, Bourges — Bourges, France (enrolling)
• Intensive care, Hospital, Colombes — Colombes, France (enrolling)
• Intensive care, Hospital, Dreux — Dreux, France (enrolling)
• Intensive care, Hospital, La Roche sur Yon — La Roche-sur-Yon, France (enrolling)
• Intensive care, Hospital, Le MANS — Le Mans, France (enrolling)
• Intensive care, Hospital, Lille — Lille, France (enrolling)
• Intensive care, Hospital, Morlaix — Morlaix, France (enrolling)
• Intensive care, Hospital, Nantes — Nantes, France (enrolling)
• Intensive care, University Hospital, Orléans — Orléans, France (enrolling)
• Intensive care, Hospital, poitiers — Poitiers, France (enrolling)
• Intensive care, Hospital, Saint Brieuc — Saint-Brieuc, France (enrolling)
• Intensive care, Hospital, Saint-Nazaire — Saint-Nazaire, France (enrolling)
• Intensive care, University Hospital, Blois — Blois, France

Full record on ClinicalTrials.gov

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