Optimisation of High Flow Oxygen Therapy Settings During Hypoxaemic Respiratory Distress Based on Non-contact Measurement of Lung Volumes by Depth Camera

Phase 3

Not yet recruiting

• Conditions: Hypoxemic Respiratory Failure
• Interventions: Drug: high flow oxygen therapy rate adjusted of lung volumes measured

• Registration Number: NCT06819644
• Lead Sponsor: University Hospital, Brest

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-16
• Study Start: 2025-02
• Study First Submitted QC: 2025-02-10
• Last Update Submitted: 2025-02-10
• Study First Posted: 2025-02-11
• Last Update Posted: 2025-02-11
• Primary Completion: 2029-05
• Study Completion: 2029-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 406

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
interventional	high flow oxygen therapy rate adjusted of lung volumes measured	The interventional arm will consist of patients with hypoxemic respiratory distress treted by high flow oxygen therapy with adjustement of ventilatory parametres based on lung volume measurements.

Primary Outcome Measures

Name	Time	Method
Use of intubation within 28 days of randomization	from patient randomization to day 90	Collection of the use of intubation (Yes/No) in patients

Secondary Outcome Measures

Name	Time	Method
Evaluation of respiratory therapy	up to 28 days after randomization	daily ROX Index
Evaluation of organ dysfunction	up to 28 days after randomization	daily SOFA score
Mortality	90 days after inclusion	Number of death
Assessment of patient comfort under high oxygen flow	up to 28 days after randomization	EVA scale
Reduced need for ventilatory techniques	from inclusion to day 28	Number of days without ventilatory support
Collection of data on clinicians' acceptance of the technique and on ergonomics	from patient inclusion to day 90	Evaluation of load task by NASA-TLX index

Trial Locations

Locations (7)

AP-HP - Hôpital Louis Mourier; 🇫🇷 Colombes, France

CH Morlaix; 🇫🇷 Morlaix, France

CH Poitiers; 🇫🇷 Poitiers, France

CHU Tours; 🇫🇷 Tours, France

AP-HP - Hôpital Henri Mondor; 🇫🇷 Créteil, France

CHU Rennes; 🇫🇷 Rennes, France

CHR Orléans; 🇫🇷 Orléans, France