Cerebral Hypoxia Clinical Trials

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IntHyx : Intubation Strategies for Patients With Acute Hypoxemic Respiratory Failure

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
France
Angers University Hospital, ICU
RECRUITING
Angers
Le Mans Hospital, ICU
NOT_YET_RECRUITING
Le Mans
Nantes University Hospital, ICU
NOT_YET_RECRUITING
Nantes
Orléans University hospital, ICU
NOT_YET_RECRUITING
Orléans
Pitié-Salpétrière Hospital, Paris University Hospital, ICU
NOT_YET_RECRUITING
Paris
Guadeloupe University Hospital, ICU
NOT_YET_RECRUITING
Pointe À Pitre
Rennes University Hospital, ICU
NOT_YET_RECRUITING
Rennes
Tours University Hospital, ICU
NOT_YET_RECRUITING
Tours
Vannes Hospital, ICU
NOT_YET_RECRUITING
Vannes
Contact Information
Primary
Mathilde TAILLANTOU-CANDAU, Doctor
Mathilde.Taillantou-candau@chu-angers.fr
+33 (0)2 41 35 58 65
Backup
Matthieu Le Lay
DRCI-Promotion-Interne@chu-angers.fr
+33 (0)2 41 35 58 91
Time Frame
Start Date: 2025-12-13
Estimated Completion Date: 2027-03
Participants
Target number of participants: 200
Treatments
Experimental: Liberal intubation strategy
Endotracheal intubation is recommended if SpO₂/FiO₂ \< 110 for more than 5 minutes.~In addition, intubation is also recommended in the liberal strategy if any of the restrictive strategy criteria occur and persist for more than 5 minutes.
Experimental: Restrictive intubation strategy
Endotracheal intubation is recommended only if at least one of the following criteria persists for more than 5 minutes:~1. Respiratory rate \> 40/min, persistent use of accessory muscles, or thoracoabdominal paradox.~2. SpO₂/FiO₂ \< 88.~3. Neurological or systemic impairment attributable to hypoxemia, defined as: altered higher brain functions without another identifiable cause, Glasgow Coma Scale ≤ 12, uncontrolled hemodynamic instability, or rising lactate levels.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Angers

This content was sourced from clinicaltrials.gov