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IntHyx : Intubation Strategies for Patients With Acute Hypoxemic Respiratory Failure

Study acronym: IntHyx
StatusRecruiting
PhaseNot applicable
Started2025-12-13
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 2026 → Dec 2027
See other at-risk trials from University Hospital, Angers

Amendment history

2026-08-04
critical
Study Status, Outcome Measures, Eligibility v2
Primary completion pushed: 2026-12 → 2027-12
Completion pushed: 2027-03 → 2028-03
Eligibility criteria+10 characters
[...] therapy ≥ 10 L/min via high-concentration mask required for 92 ≤ SpO2 ≥≤ 9298% High-flow oxygen therapy with FiO2 ≥ 50% required for 92 ≤ SpO2 ≥≤ 9298% Informed consent of the patient or a trusted relative (whe [...]
Secondary endpoints7 to 8 entries
Estimated tidal volume by Electrical impedance tomography (EIT)
2025-12-26
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-10→2026-12
Completion date2027-01→2027-03
Start dateestimated 2025-10→confirmed 2025-12-13
Study sitesdetails revised at 9 of 9 sites
2025-09-15
minor
Original filing
Acute hypoxemic respiratory failure requires endotracheal intubation and invasive mechanical ventilation in approximately 30-40% of cases, due to severe hypoxemia and/or clinical signs of acute respiratory distress. The primary objectives of invasive mechanical ventilation are to reduce respiratory effort and improve oxygenation. However, this intervention is also associated with both direct and indirect adverse effects, mainly linked to the need for sedation and often neuromuscular blockade. These include hemodynamic compromise, neuromuscular weakness, ventilator-induced lung injury, and infectious complications. An ideal intubation strategy would therefore strike a balance: avoiding the risks of delayed intubation-such as refractory hypoxemia, excessive respiratory effort, and patient self-inflicted lung injury (P-SILI)-while limiting complications associated with invasive mechanical ventilation by withholding it in patients who might otherwise recover without. To date, the optimal strategy for achieving this risk-benefit balance remains uncertain. Clinical practice suggests a broad consensus on the necessity of intubation when so-called safety criteria are met: severe hypoxemia (SaO₂/FiO₂ ratio \< 88), marked respiratory distress (use of accessory muscles, thoracoabdominal paradox, respiratory rate \> 40/min), extra-respiratory manifestations of hypoxia (e.g., altered consciousness), and/or uncontrolled hemodynamic instability. Beyond these safety thresholds, however, debate persists. Some advocate for earlier intubation-a so-called liberal approach-triggered by predefined hypoxemia criteria (e.g., SpO₂/FiO₂ \< 110), with the aim of limiting the deleterious consequences of sustained hypoxemia. In routine practice, the criteria guiding intubation vary widely between clinicians and cannot be attributed to strong scientific evidence. This study therefore seeks to compare, in a randomized interventional design, the two main strategies currently applied across centers: * Liberal intubation strategy: prioritizing the prevention of organ dysfunction related to hypoxemia (notably hypoxic cardiac arrest) and the risk of P-SILI. * Restrictive intubation strategy: prioritizing the reduction of invasive mechanical ventilation use, with the goal of minimizing ventilation-related harm and its associated therapeutic burden.
Trial Details
NCT Number NCT07189078
Lead Sponsor University Hospital, Angers
Conditions Acute Hypoxemic Respiratory Failure
Enrollment 200 participants
Start Date 2025-12-13
Primary Completion 2027-12 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-07