IntHyx : Intubation Strategies for Patients With Acute Hypoxemic Respiratory Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-13

Study Completion Date

2027-03-31

Brief Summary

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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:

* 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.

Detailed Description

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Conditions

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Acute Hypoxemic Respiratory Failure

Keywords

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Randomization Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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"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.

Group Type EXPERIMENTAL

Liberal intubation strategy

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Restrictive intubation strategy

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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:

* 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)

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mathilde TAILLANTOU-CANDAU, Doctor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

Locations

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Angers University Hospital, ICU

Angers, , France

Site Status RECRUITING