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โ† Trials
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Non-inferiority of Continuing Oral Intake Versus Fasting in Patients With Acute Respiratory Failure

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Tours
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In plain words

What the trial is, and whether it could suit you

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 pract

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Male or female โ‰ฅ 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 โ‰ฅ 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
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What it tests

  • Oral intake continuation strategy
  • Fasting strategy
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Where

14 sites
Intensive care, University Hospital, Blois
Blois, France
Intensive care, Hospital, Bourges
Bourges, France
Intensive care, Hospital, Colombes
Colombes, France
Intensive care, Hospital, Dreux
Dreux, France
Intensive care, Hospital, La Roche sur Yon
La Roche-sur-Yon, France
Intensive care, Hospital, Le MANS
Le Mans, France
Intensive care, Hospital, Lille
Lille, France
Intensive care, Hospital, Morlaix
Morlaix, France

โ€ฆand 6 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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