IntHyx : Intubation Strategies for Patients With Acute Hypoxemic Respiratory Failure

NCT07189078 | Recruiting

• 2 other identifiers: 49RC24_02932025-A01380-49
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Acute Hypoxemic Respiratory Failure

Keywords

Randomization; Intubation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Evaluate the impact of the intubation strategy on intubation rates over time.

  Day 28

• Assess the impact of the intubation strategy on each component 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.

  Day 28

• Assess the impact of the intubation strategy on quality of life at day 90.

  Day 90

• Assess the impact of the intubation strategy on the rate of procedure-related adverse events.

  within 30 minutes of the start of the intubation procedure

Study Arms (2)

"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.

Procedure: Liberal intubation strategy

Restrictive intubation strategy

EXPERIMENTAL

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.

Procedure: Restrictive intubation strategy

Interventions

Restrictive intubation strategy PROCEDURE

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.

Restrictive intubation strategy

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.

"Liberal" intubation strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Acute hypercapnic respiratory failure (defined by 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
• Decision to intubate immediately
• Invasive mechanical ventilation within the previous 7 days
• Treatment limitation decisions for intubation
• Person deprived of liberty by judicial or administrative decision : Person undergoing compulsory psychiatric care, person subject to legal protection measures, Pregnant, breastfeeding, or parturient patient

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (9)

Angers University Hospital, ICU

Angers, France

RECRUITING

Le Mans Hospital, ICU

Le Mans, France

NOT YET RECRUITING

Nantes University Hospital, ICU

Nantes, France

NOT YET RECRUITING

Orléans University hospital, ICU

Orléans, France

NOT YET RECRUITING

Pitié-Salpétrière Hospital, Paris University Hospital, ICU

Paris, France

NOT YET RECRUITING

Guadeloupe University Hospital, ICU

Pointe à Pitre, France

NOT YET RECRUITING

Rennes University Hospital, ICU

Rennes, France

NOT YET RECRUITING

Tours University Hospital, ICU

Tours, France

NOT YET RECRUITING

Vannes Hospital, ICU

Vannes, France

NOT YET RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Mathilde TAILLANTOU-CANDAU, Doctor

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 23, 2025
• Study Start: December 13, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)