Actively Recruiting
IntHyx: Comparing Liberal and Restrictive Intubation Strategies for Acute Hypoxemic Respiratory Failure
Led by University Hospital, Angers · Updated on 2025-12-29
200
Participants Needed
9
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two intubation strategies for adults with acute hypoxemic respiratory failure, a condition where severe low oxygen levels may require invasive mechanical ventilation. The study aims to find the best balance between preventing organ damage caused by low oxygen or excessive breathing effort and avoiding complications from mechanical ventilation, which can include sedation effects, muscle weakness, lung injury, and infections. The trial compares a liberal intubation approach, which recommends earlier intubation based on oxygen levels, to a restrictive approach, which limits intubation to more severe clinical signs. Participants are randomly assigned to one of two intubation strategies. The liberal strategy advises intubation if oxygen saturation to inspired oxygen fraction ratio (SpO2/FiO2) falls below 110 for more than 5 minutes, or if restrictive criteria are met and persist. The restrictive strategy recommends intubation only if certain safety criteria persist for over 5 minutes, including very low oxygen levels (SpO2/FiO2 < 88), rapid breathing with accessory muscle use, neurological impairments, or unstable blood pressure. The study tracks intubation decisions and outcomes over the course of treatment. During the study, researchers monitor participants for organ support duration while considering mortality at 28 days, intubation rates, vital organ function, quality of life at 90 days, and adverse events related to intubation or ventilation. The study collects data on procedure-related complications shortly after intubation and follows participants closely throughout their intensive care stay. The trial runs until March 2027, involving adults recently admitted to intensive care with acute respiratory failure requiring significant oxygen support.
CONDITIONS
Brief Title
IntHyx : Intubation Strategies for Patients With Acute Hypoxemic Respiratory Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient aged 18 years or older
- Admitted to intensive care less than 24 hours ago
- Acute respiratory failure with hypoxemia needing oxygen therapy of 10 L/min or more via high-concentration mask to maintain SpO2 ≥ 92%
- Or receiving high-flow oxygen therapy with FiO2 ≥ 50% to maintain SpO2 ≥ 92%
- Informed consent given by patient or trusted relative if patient unable to consent
You will not qualify if you...
- Acute hypercapnic respiratory failure with 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 before study enrollment
- Invasive mechanical ventilation within previous 7 days
- Decisions limiting intubation treatment
- Person deprived of liberty by judicial or administrative decision
- Undergoing compulsory psychiatric care
- Subject to legal protection measures
- Pregnant, breastfeeding, or parturient patient
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days
Participants are assigned to either a liberal or restrictive intubation strategy to manage acute hypoxemic respiratory failure. Intubation is performed based on specific clinical criteria depending on the assigned strategy.
Daily assessments during treatment
Duration - Up to 90 days
Participants are monitored to assess quality of life and any adverse events related to the intubation strategy after treatment ends.
1 visit at day 90
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
M
Matthieu Le Lay
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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