Continuing oral intake versus fasting for adults with acute respiratory failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Piotr SZYCHOWIAK, MD
• Email: piotr.szychowiak@gmail.com
• Phone: 2.38.22.95.58

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.