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NCT Number: NCT06819644

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Brest, University Hospital, Brest, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

high flow oxygen therapy rate adjusted of lung volumes measured

Drug

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.

Primary outcomes

  1. Use of intubation within 28 days of randomization

    Time frame: from patient randomization to day 90

    Collection of the use of intubation (Yes/No) in patients

Secondary outcomes

  1. Evaluation of organ dysfunction

    Time frame: up to 28 days after randomization

    daily SOFA score

  2. Evaluation of respiratory therapy

    Time frame: up to 28 days after randomization

    daily ROX Index

  3. Reduced need for ventilatory techniques

    Time frame: from inclusion to day 28

    Number of days without ventilatory support

  4. Mortality

    Time frame: 90 days after inclusion

    Number of death

  5. Collection of data on clinicians' acceptance of the technique and on ergonomics

    Time frame: from patient inclusion to day 90

    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'.

  6. Collection of data on clinicians' acceptance of the technique and on ergonomics

    Time frame: from patient inclusion to day 90

    Evaluation of load task by NASA-TLX index

  7. Assessment of patient comfort under high oxygen flow

    Time frame: up to 28 days after randomization

    EVA scale

Study contacts

Contact information is provided by the study sponsor or research team.

Laetitia BODENES, Dr

CONTACT

[email protected]

+33 2 30 33 76 78

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: DiStok

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 11, 2025
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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