Intubation strategies for adults with acute hypoxemic 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 randomized interventional trial enrolls adults admitted to the ICU within 24 hours who have acute hypoxemic respiratory failure meeting prespecified oxygen requirements. Participants are randomized to a restrictive intubation strategy or a liberal intubation strategy and managed according to the assigned protocol. The trial compares timing and indications for endotracheal intubation, with outcomes focused on need for invasive mechanical ventilation, complications related to ventilation and clinical status. The goal is to identify an approach that balances risks of delayed intubation against harms of unnecessary invasive ventilation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patient
* Patient admitted to intensive care less than 24 hours ago
* Acute respiratory failure with hypoxemia defined by either:

  * Oxygen therapy ≥ 10 L/min via high-concentration mask required for 92 ≤ SpO2 ≤ 98%
  * High-flow oxygen therapy with FiO2 ≥ 50% required for 92 ≤ SpO2 ≤ 98%
* Informed consent of the patient or a trusted relative (when the patient is unable to give consent)

Exclusion Criteria:

* Acute hypercapnic respiratory failure (defined by PaCO2 \> 45 mmHg)
* Cardiogenic pulmonary edema
* Exacerbation of chronic respiratory disease
* Respiratory failure requiring long-term oxygen therapy
* Neuromuscular disease
* Glasgow Coma Scale score ≤ 12
* Decision to intubate immediately
* Invasive mechanical ventilation within the previous 7 days
* Treatment limitation decisions for intubation
* Person deprived of liberty by judicial or administrative decision : Person undergoing compulsory psychiatric care, person subject to legal protection measures, Pregnant, breastfeeding, or parturient patient

Where it's running

• Angers University Hospital, ICU
  Angers, France Recruiting
• Le Mans Hospital, ICU
  Le Mans, France Not yet recruiting
• Nantes University Hospital, ICU
  Nantes, France Not yet recruiting
• Orléans University hospital, ICU
  Orléans, France Not yet recruiting
• Pitié-Salpétrière Hospital, Paris University Hospital, ICU
  Paris, France Not yet recruiting
• Guadeloupe University Hospital, ICU
  Pointe à Pitre, France Not yet recruiting

Study contacts

• Principal investigator: Mathilde TAILLANTOU-CANDAU, Doctor — University Hospital, Angers
• Study coordinator: Mathilde TAILLANTOU-CANDAU, Doctor
• Email: Mathilde.Taillantou-candau@chu-angers.fr
• Phone: +33 (0)2 41 35 58 65

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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.