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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A01380-49 | Other Identifier | French National Drug Regulatory Authority (ANSM) |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Liberal" intubation strategy | Experimental | 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. |
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| Restrictive intubation strategy | Experimental | Endotracheal intubation is recommended only if at least one of the following criteria persists for more than 5 minutes:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restrictive intubation strategy | Procedure | Endotracheal intubation is recommended only if at least one of the following criteria persists for more than 5 minutes:
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| Measure | Description | Time Frame |
|---|---|---|
| Impact of a liberal intubation strategy compared to a restrictive strategy in regards to organ support duration, taking mortality into account | Composite endpoint consisting of death and number of days with organ failure at D28, analyzed using the Win Ratio method. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the impact of the intubation strategy on intubation rates over time. | Time of intubation (if performed). | Day 28 |
| Assess the impact of the intubation strategy on each component of the composite primary endpoint. |
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Inclusion Criteria:
Adult patient
Patient admitted to intensive care less than 24 hours ago
Acute respiratory failure with hypoxemia defined by either:
Informed consent of the patient or a trusted relative (when the patient is unable to give consent)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mathilde TAILLANTOU-CANDAU, Doctor | Contact | +33 (0)2 41 35 58 65 | Mathilde.Taillantou-candau@chu-angers.fr | |
| Matthieu Le Lay | Contact | +33 (0)2 41 35 58 91 | DRCI-Promotion-Interne@chu-angers.fr |
| Name | Affiliation | Role |
|---|---|---|
| Mathilde TAILLANTOU-CANDAU, Doctor | University Hospital, Angers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angers University Hospital, ICU | Recruiting | Angers | France |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Liberal intubation strategy | Procedure | 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. |
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Components of the composite primary endpoint:
| Day 28 |
| Assess the impact of the intubation strategy on the severity of vital organ failure and the duration of care. | Measurements of SOFA score (points), Length of stay in the intensive care unit (days) and total hospital length of stay (days) SOFA is Sepsis-related Organ Failure Assessment : score range form 0 to 24, the higher scores indicating the the more severe condition | Day 28 |
| Assess the impact of the intubation strategy on quality of life at day 90. | 5Level-EuroQuol-5Dimensions score (EQ-5D-5L). The scale measures quality of life on a 5-component scale. A health state of 11,111 indicate no problem in any dimension, a health state of 55,555 indicates extreme problems in every dimension | Day 90 |
| Assess the impact of the intubation strategy on the rate of procedure-related adverse events. | Endpoint: Occurrence, within 30 minutes of the start of the intubation procedure, of any of the following events:
| within 30 minutes of the start of the intubation procedure |
| Assess the impact of the intubation strategy on the rate of adverse events related to invasive mechanical ventilation. | Occurrence, at any time up to day 28, of any of the following events:
| Day 28 |
| Assess the impact of the intubation strategy on the rate of adverse events potentially related to delayed intubation. | Occurrence of any of the following events:
| Day 28 |
| Le Mans Hospital, ICU | Not yet recruiting | Le Mans | France |
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| Nantes University Hospital, ICU | Not yet recruiting | Nantes | France |
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| Orléans University hospital, ICU | Not yet recruiting | Orléans | France |
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| Pitié-Salpétrière Hospital, Paris University Hospital, ICU | Not yet recruiting | Paris | France |
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| Guadeloupe University Hospital, ICU | Not yet recruiting | Pointe à Pitre | France |
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| Rennes University Hospital, ICU | Not yet recruiting | Rennes | France |
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| Tours University Hospital, ICU | Not yet recruiting | Tours | France |
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| Vannes Hospital, ICU | Not yet recruiting | Vannes | France |
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