Actively Recruiting
IntHyx : Intubation Strategies for Patients With Acute Hypoxemic Respiratory Failure
Led by University Hospital, Angers · Updated on 2025-12-29
200
Participants Needed
9
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
IntHyx : Intubation Strategies for Patients With Acute Hypoxemic Respiratory Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 if patient is unable to consent
You will not qualify if you...
- Acute hypercapnic respiratory failure (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
- Immediate decision to intubate
- Invasive mechanical ventilation within previous 7 days
- Treatment limitation decisions for intubation
- Persons deprived of liberty by judicial or administrative decision
- Persons undergoing compulsory psychiatric care
- Persons subject to legal protection measures
- Pregnant, breastfeeding, or parturient patients
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Trial Site Locations
Total: 9 locations
1
Angers University Hospital, ICU
Angers, France
Actively Recruiting
2
Le Mans Hospital, ICU
Le Mans, France
Not Yet Recruiting
3
Nantes University Hospital, ICU
Nantes, France
Not Yet Recruiting
4
Orléans University hospital, ICU
Orléans, France
Not Yet Recruiting
5
Pitié-Salpétrière Hospital, Paris University Hospital, ICU
Paris, France
Not Yet Recruiting
6
Guadeloupe University Hospital, ICU
Pointe à Pitre, France
Not Yet Recruiting
7
Rennes University Hospital, ICU
Rennes, France
Not Yet Recruiting
8
Tours University Hospital, ICU
Tours, France
Not Yet Recruiting
9
Vannes Hospital, ICU
Vannes, France
Not Yet Recruiting
Research Team
M
Mathilde TAILLANTOU-CANDAU, Doctor
CONTACT
M
Matthieu Le Lay
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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