Status:
NOT_YET_RECRUITING
Non-inferiority of a Strategy of Continuing Oral Intake Compared With Fasting
Lead Sponsor:
University Hospital, Tours
Conditions:
Patient in Acute Respiratory Failure
Continuation of Oral Intake
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Fasting in the intensive care unit is a crucial issue and has been studied in particular in patients on mechanical ventilation or at the time of weaning. To date, there are no data on fasting in patie...
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 :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
754 Patients enrolled
Trial Details
Trial ID
NCT06510972
Start Date
September 1 2024
End Date
October 1 2027
Last Update
July 19 2024
Active Locations (11)
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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