Clinical trial NCT06819644: Optimisation of High Flow Oxygen Therapy Settings During Hypoxaemic Respiratory Distress Based on Non-contact Measurement of Lung Volumes by Depth Camera
Official title: Optimisation of High Flow Oxygen Therapy Settings During Hypoxaemic Respiratory Distress Based on Non-contact Measurement of Lung Volumes by Depth Camera
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Hypoxemic Respiratory Failure
Keywords: flow oxygen
lung volume
depth camera
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to validate the interest of a strategy adjusting the flow rate delivered under high-flow oxygen (HFO) therapy according to the lung volumes measured by a new technique, in intensive care patients with hypoxemic respiratory distress (HRD).

The main question it aims to answer is:

"The use of a technique of measurement of lung pulmonary with adjustement to the flow rate can make it possible to limite intubation in patients with HRD in intensive care?" The participants will be the patients admitted in intensive care for HRD with the need for treatment with HFO.

This participants will be randomized in :

* the arm control: treated by high flow oxygen therapy according to standard procedures.
* or in the experimental arm : treated by high flow oxygen therapy with adjustement of ventilatory parametres based on lung volume measurements, obtained by the depth camera.

Detailed description: High-flow oxygen therapy (HFO) is a common technique for the management of patient with hypoxemic respiratory distress in intensive care.The variations in lung volumes induced by the HFO in patients is unknown in clinical routine, in the absence of the availability of a effective measurement technique.

The investigators research team validated a new non-invasive, non-contact technique for measuring lung volumes using depth camera. Using a stereoscopic camera, the patient's chest and abdomen are recognized by a artificial intelligence algorithms. The structures of interest of the chest and the abdomen are the identified and the variation in depth of these points in space allows both the integration of lung volume through automatic calibration procedures, the measurement of respiratory rate and comparaison of movement symetries.

Eligibility criteria: Inclusion Criteria:

* Patients with hypoxemic respiratory distress define by the following 4 criteria:
* Respiratory rate ≥ 25 breaths per minutes
* A ratio of the partial pressure of arterial oxygen (PaO2) to the FiO2 ≤ 300 mmHg while the patient is breathing oxygen at a flow rate of 10 liters per minutes or more
* A partial pressure of arterial carbon dioxide (PaCO2) not higher than 45 mmHg
* An absence of clinical history of underlying chronic respiratory failure

Exclusion Criteria:

* A do-not-intubate order
* Pregnant or lactating woman
* Cardiogenic pulmonary edema
* Exacerbation of asthma
* Hemodynamic instability with use of vasopressor at significant dose (norepinephrine \> 0.5 mg/h)
* A Glasgow Coma Scale of 12 points of less
* Contraindications to non-invasive ventilation
* Urgent need for endotracheal intubation
* High flow oxygen therapy started within 48 hours before inclusion
* Patient under legal protection or deprived of liberty

Primary outcomes:
measure: Use of intubation within 28 days of randomization
timeFrame: from patient randomization to day 90
Secondary outcomes:
measure: Evaluation of organ dysfunction
timeFrame: up to 28 days after randomization
measure: Evaluation of respiratory therapy
timeFrame: up to 28 days after randomization
measure: Reduced need for ventilatory techniques
timeFrame: from inclusion to day 28
measure: Mortality
timeFrame: 90 days after inclusion
measure: Collection of data on clinicians' acceptance of the technique and on ergonomics
timeFrame: from patient inclusion to day 90
measure: Collection of data on clinicians' acceptance of the technique and on ergonomics
timeFrame: from patient inclusion to day 90
measure: Assessment of patient comfort under high oxygen flow
timeFrame: up to 28 days after randomization
Other outcomes:
Locations:
city: Colombes
country: France
facility: AP-HP - Hôpital Louis Mourier
city: Créteil
country: France
facility: AP-HP - Hôpital Henri Mondor
city: Morlaix
country: France
facility: CH Morlaix
city: Orléans
country: France
facility: CHR Orléans
city: Poitiers
country: France
facility: CH Poitiers
city: Rennes
country: France
facility: CHU Rennes
city: Tours
country: France
facility: CHU Tours
Study officials:
References: