Status:
RECRUITING
Non-inferiority of Continuing Oral Intake Versus Fasting in Patients With Acute Respiratory Failure
Lead Sponsor:
University Hospital, Tours
Conditions:
Respiratory Insufficiency
Fasting
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 e...
Detailed Description
Fasting in intensive care is a crucial issue that has primarily been studied in mechanically ventilated patients or during the mechanical ventilation weaning process. This practice has recently been c...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
February 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
754 Patients enrolled
Trial Details
Trial ID
NCT06510972
Start Date
February 5 2025
End Date
March 1 2028
Last Update
February 18 2026
Active Locations (14)
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1
Intensive care, University Hospital, Blois
Blois, France
2
Intensive care, Hospital, Bourges
Bourges, France
3
Intensive care, Hospital, Colombes
Colombes, France
4
Intensive care, Hospital, Dreux
Dreux, France