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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypoxemic Respiratory Failure
• Intervention / Treatment: Drug: high flow oxygen therapy rate adjusted of lung volumes measured

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 Type: Interventional
• Enrollment (Estimated): 406
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Laetitia BODENES, Dr; Phone Number: +33 2 30 33 76 78; Email: laetitia.bodenes@chu-brest.fr

Study Locations

• France
  • Colombes, France, 92700
    • AP-HP - Hôpital Louis Mourier
    • Contact: Jean-Damien RICARD, Prof; Phone Number: +33 1 47 60 61 91; Email: jean-damien.ricard@aphp.fr
  • Créteil, France, 94010
    • AP-HP - Hôpital Henri Mondor
    • Contact: Armand MEKONTSO-DESSAP, Prof; Phone Number: +33 1 49 81 23 91; Email: armand.dessap@aphp.fr
  • Morlaix, France, 29672
    • CH Morlaix
    • Contact: Pierre-Yves EGRETEAU, Dr; Phone Number: +33 2 98 62 60 95; Email: pyegreteau@ch-morlaix.fr
  • Orléans, France, 45067
    • CHR Orléans
    • Contact: Mai-Anh NAY, Dr; Phone Number: +33 2 38 57 52 53; Email: mai-anh.nay@chr-orleans.fr
  • Poitiers, France, 86000
    • CH Poitiers
    • Contact: Jean-Pierre FRAT, Dr; Phone Number: +33 5 49 44 44 44; Email: Jean-pierre.frat@chu-poitiers.fr
  • Rennes, France, 35033
    • Chu Rennes
    • Contact: Nicolas TERZI, Dr; Phone Number: +33 4 76 76 71 09; Email: nicolas.terzi@chu-rennes.fr
  • Tours, France, 37044
    • CHU Tours
    • Contact: Pierre-François DEQUIN, Dr; Phone Number: +33 2 47 47 38 55; Email: pierre-francois.dequin@univ-tours.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; The control arm will consist of patients with hypoxemic respiratory distress treated by high flow oxygen therapy according to standard procedures.
Experimental: interventional; 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.	Drug: high flow oxygen therapy rate adjusted of lung volumes measured; Use of a technique based on non-contact measurement of lung volumes by depth camera in order to optimise the use of hihg flow oxygen therapy, with adaptation of the flow rate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of intubation within 28 days of randomization	Collection of the use of intubation (Yes/No) in patients	from patient randomization to day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of organ dysfunction	daily SOFA score	up to 28 days after randomization
Evaluation of respiratory therapy	daily ROX Index	up to 28 days after randomization
Reduced need for ventilatory techniques	Number of days without ventilatory support	from inclusion to day 28
Mortality	Number of death	90 days after inclusion
Collection of data on clinicians' acceptance of the technique and on ergonomics	Evaluation of ergonomy by the System Usability Scale (SUS). The SUS is based on a Likert scale that allows the user to respond on a 5-point scale from 1:'Strongly disagree' to 5:'Strongly agree'.	from patient inclusion to day 90
Collection of data on clinicians' acceptance of the technique and on ergonomics	Evaluation of load task by NASA-TLX index	from patient inclusion to day 90
Assessment of patient comfort under high oxygen flow	EVA scale	up to 28 days after randomization

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: lung volume; flow oxygen; depth camera
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 29BRC22.0105; 2022-A01149-34 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No