NCT06510972 Non-inferiority of Continuing Oral Intake Versus Fasting in Patients With Acute Respiratory Failure
| NCT ID | NCT06510972 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Tours |
| Condition | Respiratory Insufficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 754 participants |
| Start Date | 2025-02-05 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 754 participants in total. It began in 2025-02-05 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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
Contact & Investigator
Piotr SZYCHOWIAK, MD
STUDY DIRECTOR
University Hospital, Orléans
Frequently Asked Questions
Who can join the NCT06510972 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Respiratory Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06510972 currently recruiting?
Yes, NCT06510972 is actively recruiting participants. Contact the research team at piotr.szychowiak@gmail.com for enrollment information.
Where is the NCT06510972 trial being conducted?
This trial is being conducted at Blois, France, Bourges, France, Colombes, France, Dreux, France and 10 additional locations.
Who is sponsoring the NCT06510972 clinical trial?
NCT06510972 is sponsored by University Hospital, Tours. The principal investigator is Piotr SZYCHOWIAK, MD at University Hospital, Orléans. The trial plans to enroll 754 participants.