Acute Hypoxemic Respiratory FailureIntHyxNCT07189078
IntHyx : Intubation Strategies for Patients With Acute Hypoxemic Respiratory Failure
A study testing Restrictive intubation strategy and Liberal intubation strategy in people with Acute Hypoxemic Respiratory Failure, run by University Hospital, Angers at 9 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure
- What is being tested?
- Restrictive intubation strategy and Liberal intubation strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 9 sitesFrance
- Study dates
- 13 Dec 2025to Mar 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 92 ≤ SpO2 ≤ 98%
- High-flow oxygen therapy with FiO2 ≥ 50% required for 92 ≤ SpO2 ≤ 98%
- Informed consent of the patient or a trusted relative (when the patient is unable to give consent)
Who cannot join
- 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
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- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mathilde TAILLANTOU-CANDAU, Doctor contact
9 sites in 1 country
France9 sites, 9 recruiting
- Recruiting
Angers University Hospital, ICU
Angers
Mathilde TAILLANTOU-CANDAU, Doctor, +33 (0)2 41 35 58 65, Mathilde.Taillantou-candau@chu-angers.fr
- Not yet recruiting
Le Mans Hospital, ICU
Le Mans
Christophe GUITTON, Professor, +33 (0)2 43 43 24 58, cguitton@ch-lemans.fr
- Not yet recruiting
Nantes University Hospital, ICU
Nantes
Jean REIGNIER, Professor, +33 (0)2 40 08 73 65, jean.reignier@chu-nantes.fr
- Not yet recruiting
Orléans University hospital, ICU
Orléans
Mai-Anh NAY, Doctor, +33 (0)2 38 51 44 46, mai-anh.nay@chr-orleans.fr
- Not yet recruiting
Pitié-Salpétrière Hospital, Paris University Hospital, ICU
Paris
Martin DRES, Professor, +33 (0)1 42 16 77 97, martin.dres@aphp.fr
- Not yet recruiting
Guadeloupe University Hospital, ICU
Pointe à Pitre
Frédéric MARTINO, Doctor, +33 (0)5 90 89 11 30, frederic.martino@chu-guadeloupe.fr
- Not yet recruiting
Rennes University Hospital, ICU
Rennes
Arnaud GACOUIN, Doctor, +33 (0)2 99 28 42 48, arnaud.gacouin@chu-rennes.fr
- Not yet recruiting
Tours University Hospital, ICU
Tours
Pierre-François DEQUIN, Professor, +33 (0)2 47 47 38 55, pf.dequin@chu-tours.fr
- Not yet recruiting
Vannes Hospital, ICU
Vannes
Agathe DELBOVE, Doctor, +33 (0)2 97 01 43 06, agathe.delbove@ch-bretagne-atlantique.fr
About this study
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.
Read more
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
- Being tested
- Restrictive intubation strategy, Liberal intubation strategy
- Keywords
- Randomization, Intubation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restrictive intubation strategyProcedure or surgery
Endotracheal intubation is recommended only if at least one of the following criteria persists for more than 5 minutes:
- Respiratory rate > 40/min, persistent use of accessory muscles, or thoracoabdominal paradox.
- SpO₂/FiO₂ < 88.
- 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.
Liberal intubation strategyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| "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. Receives: 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. Receives: Procedure: Restrictive intubation strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 28
Secondary outcomes (8)
Evaluate the impact of the intubation strategy on intubation rates over time.
Time of intubation (if performed).
Measured: Day 28
Assess the impact of the intubation strategy on each component of the composite primary endpoint.
Components of the composite primary endpoint:
- All-cause mortality
- Duration of mechanical ventilation
- Duration of vasopressor support
- Duration of renal replacement therapy
Measured: Day 28
Assess the impact of the intubation strategy on the severity of vital organ failure and the duration of care.
Measurements of SOFA score (points), Length of stay in the intensive care unit (days) and total hospital length of stay (days) SOFA is Sepsis-related Organ Failure Assessment : score range form 0 to 24, the higher scores indicating the the more severe condition
Measured: Day 28
Assess the impact of the intubation strategy on quality of life at day 90.
5Level-EuroQuol-5Dimensions score (EQ-5D-5L). The scale measures quality of life on a 5-component scale. A health state of 11,111 indicate no problem in any dimension, a health state of 55,555 indicates extreme problems in every dimension
Measured: Day 90
Assess the impact of the intubation strategy on the rate of procedure-related adverse events.
Endpoint: Occurrence, within 30 minutes of the start of the intubation procedure, of any of the following events:
- SpO₂ decrease to less than 80%;
- Hemodynamic instability (defined as: Systolic blood pressure <65 mmHg recorded at least once, or Systolic blood pressure <90 mmHg for more than 30 minutes despite adequate volume resuscitation, or New requirement for vasopressors or an increase in vasopressor dose by more than 30%)
- Cardiac arrest;
- Severe arrhythmia.
Measured: within 30 minutes of the start of the intubation procedure
Assess the impact of the intubation strategy on the rate of adverse events related to invasive mechanical ventilation.
Occurrence, at any time up to day 28, of any of the following events:
- Ventilator-associated pneumonia;
- other nosocomial infection
- Pneumothorax;
- Delirium (as assessed by CAM-ICU score).
- General weakness (defined by MRC score < 48/60)
Measured: Day 28
Assess the impact of the intubation strategy on the rate of adverse events potentially related to delayed intubation.
Occurrence of any of the following events:
- Cardiac arrest in a non-intubated patient;
- Need for emergency intubation that could not be safely delayed by 10 minutes;
- Aspiration pneumonia.
Measured: Day 28
Estimated tidal volume by Electrical impedance tomography (EIT)
Exploratory objective, in participating centers equipped with EIT: estimation of tidal volume using EIT to compare the measured values in intubated and non-intubated patients in each group
Measured: 1 hour, 24 hours, and 48 hours after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start13 Dec 2025
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mathilde TAILLANTOU-CANDAU, Doctor, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189078
- Sponsor's protocol ID
- 49RC24_0293
- Other IDs
- 2025-A01380-49
- Acronym
- IntHyx
- Status last verified
- Aug 2026
- First submitted
- 29 Aug 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No