Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07189078

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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