Intubation strategies for adults with acute hypoxemic respiratory failure
IntHyx : Intubation Strategies for Patients With Acute Hypoxemic Respiratory Failure
This trial will test two different rules for when to intubate adults with acute hypoxemic respiratory failure to see which approach keeps patients safer while avoiding unnecessary mechanical ventilation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Angers Government |
| Locations | 9 sites (Angers and 8 other locations) |
| Trial ID | NCT07189078 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults admitted to an ICU within the last 24 hours with acute hypoxemic respiratory failure requiring high-concentration oxygen (≥10 L/min) or high-flow oxygen (FiO2 ≥50%) to maintain SpO2 ≥92% and who can provide consent or have a proxy.
Not a fit: Patients with acute hypercapnic respiratory failure, cardiogenic pulmonary edema, recent invasive ventilation, neuromuscular disease, immediate need for intubation, or other listed exclusions are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the trial could reduce unnecessary intubations and related complications while preventing harm from delayed ventilation, improving overall patient outcomes.
How similar studies have performed: Some observational studies and smaller trials have examined timing of intubation, but randomized comparisons of restrictive versus liberal intubation strategies remain limited, making this approach relatively novel in rigorous RCT form.
Eligibility criteria
Show full inclusion / exclusion criteria
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 SpO2 ≥ 92% * High-flow oxygen therapy with FiO2 ≥ 50% required for SpO2 ≥ 92% * 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 this trial is running
Angers and 8 other locations
- 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)
- Rennes University Hospital, ICU — Rennes, France (Not_yet_recruiting)
- Tours University Hospital, ICU — Tours, France (Not_yet_recruiting)
- Vannes Hospital, ICU — Vannes, 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
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.