Actively Recruiting
Non-inferiority of Continuing Oral Intake Versus Fasting in Patients With Acute Respiratory Failure
Led by University Hospital, Tours · Updated on 2026-02-18
754
Participants Needed
14
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Non-inferiority of Continuing Oral Intake Versus Fasting in Patients With Acute Respiratory Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Affiliated with a social security scheme
- Provide oral consent, or consent from a trusted person or next of kin
- Hospitalized in an intensive care or continuous surveillance unit for less than 24 hours
- Diagnosed with acute hypoxaemic respiratory failure defined by respiratory rate over 25 breaths per minute or confirmed SARS-CoV-2 infection
- Oxygenation status with PaO2/FiO2 less than 200 mmHg or SpO2/FiO2 less than 235 while on at least 10 L/min high concentration oxygen mask
You will not qualify if you...
- Need for immediate intubation due to worsening respiratory failure, acidosis, severe hypoxia, or other clinical signs
- Major hemodynamic failure requiring increasing vasopressor support
- Neurological failure with Glasgow coma score less than 8
- Cardiac or respiratory arrest
- Severe chronic lung disease (COPD GOLD grade 3 or 4) or other chronic lung diseases needing long-term oxygen or ventilation
- Known swallowing difficulties or contraindications to oral nutrition
- Presence of feeding tubes such as nasogastric, orogastric, jejunostomy, or feeding ileostomy
- Already on invasive mechanical ventilation at admission
- Decisions limiting therapy including no intubation orders
- Legal incapacity (guardianship or curatorship)
- Pregnant, in labor, or breastfeeding
- Having a tracheostomy
- Previously enrolled in this study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 14 locations
1
Intensive care, University Hospital, Blois
Blois, France
Not Yet Recruiting
2
Intensive care, Hospital, Bourges
Bourges, France
Actively Recruiting
3
Intensive care, Hospital, Colombes
Colombes, France
Actively Recruiting
4
Intensive care, Hospital, Dreux
Dreux, France
Actively Recruiting
5
Intensive care, Hospital, La Roche sur Yon
La Roche-sur-Yon, France
Actively Recruiting
6
Intensive care, Hospital, Le MANS
Le Mans, France
Actively Recruiting
7
Intensive care, Hospital, Lille
Lille, France
Actively Recruiting
8
Intensive care, Hospital, Morlaix
Morlaix, France
Actively Recruiting
9
Intensive care, Hospital, Nantes
Nantes, France
Actively Recruiting
10
Intensive care, University Hospital, Orléans
Orléans, France
Actively Recruiting
11
Intensive care, Hospital, poitiers
Poitiers, France
Actively Recruiting
12
Intensive care, Hospital, Saint Brieuc
Saint-Brieuc, France
Actively Recruiting
13
Intensive care, Hospital, Saint-Nazaire
Saint-Nazaire, France
Actively Recruiting
14
Intensive care, University Hospital, Tours
Tours, France
Actively Recruiting
Research Team
P
Piotr SZYCHOWIAK, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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