Continuing oral intake versus fasting for adults with acute respiratory failure
Continuation of Oral Intake Compared With Fasting in Patients With Acute Respiratory Failure Before Intubation : a Non-inferiority Randomized Clinical Trial
This trial tests if letting adults in the ICU with acute respiratory failure continue oral intake is as safe as keeping them fasting.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 754 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Tours Academic / other |
| Locations | 14 sites (Blois and 13 other locations) |
| Trial ID | NCT06510972 on ClinicalTrials.gov |
What this trial studies
This is a non-inferiority, interventional trial comparing a strategy of continuing oral intake to a strategy of fasting in non-intubated adults admitted to intensive care with acute hypoxemic respiratory failure. Eligible patients are randomized shortly after ICU admission and followed for events such as aspiration, need for intubation, tolerance of oral intake, and nutritional intake. The protocol targets patients meeting defined oxygenation and respiratory rate criteria and excludes those requiring immediate intubation or with clear contraindications to oral feeding. Outcomes will measure safety (aspiration and intubation rates) and potential benefits like caloric delivery and patient comfort.
Who should consider this trial
Good fit: Adults (≥18) admitted to a participating ICU with acute hypoxaemic respiratory failure who are not immediately intubation-bound and meet the study oxygenation and respiratory rate criteria are ideal candidates.
Not a fit: Patients who need immediate intubation, have impaired airway protective reflexes, or other contraindications to oral intake are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the approach could let more patients maintain nutrition and comfort without increasing aspiration or intubation risk.
How similar studies have performed: Related research showed benefits of continuing enteral nutrition around extubation in ventilated patients, but fasting strategies in non-intubated acute respiratory failure patients remain largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 this trial is running
Blois and 13 other locations
- Intensive care, University Hospital, Blois — Blois, France (Not_yet_recruiting)
- Intensive care, Hospital, Bourges — Bourges, France (Recruiting)
- Intensive care, Hospital, Colombes — Colombes, France (Recruiting)
- Intensive care, Hospital, Dreux — Dreux, France (Recruiting)
- Intensive care, Hospital, La Roche sur Yon — La Roche-sur-Yon, France (Recruiting)
- Intensive care, Hospital, Le MANS — Le Mans, France (Recruiting)
- Intensive care, Hospital, Lille — Lille, France (Recruiting)
- Intensive care, Hospital, Morlaix — Morlaix, France (Recruiting)
- Intensive care, Hospital, Nantes — Nantes, France (Recruiting)
- Intensive care, University Hospital, Orléans — Orléans, France (Recruiting)
- Intensive care, Hospital, poitiers — Poitiers, France (Recruiting)
- Intensive care, Hospital, Saint Brieuc — Saint-Brieuc, France (Recruiting)
- Intensive care, Hospital, Saint-Nazaire — Saint-Nazaire, France (Recruiting)
- Intensive care, University Hospital, Tours — Tours, France (Recruiting)
Study contacts
- Study coordinator: Piotr SZYCHOWIAK, MD
- Email: piotr.szychowiak@gmail.com
- Phone: 2.38.22.95.58
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.