Hypoxemic Respiratory FailurePhase 3DiStokNCT06819644
Optimisation of High Flow Oxygen Therapy Settings During Hypoxaemic Respiratory Distress Based on Non-contact Measurement of Lung Volumes by Depth Camera
A Phase 3 study testing high flow oxygen therapy rate adjusted of lung volumes measured in people with Hypoxemic Respiratory Failure, run by University Hospital, Brest at 8 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemic Respiratory Failure
- What is being tested?
- high flow oxygen therapy rate adjusted of lung volumes measured
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 8 sitesFrance
- Study dates
- 8 Apr 2026to Oct 2030
- Phase
- Phase 3
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
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
Brest, University Hospital
Brest
Laetitia Bodenes, Dr, +33 2 30 33 76 78 ext. +33, laetitia.bodenes@chu-brest.fr
- Not yet recruiting
AP-HP - Hôpital Louis Mourier
Colombes, 92700
Jean-Damien RICARD, Prof, +33 1 47 60 61 91, jean-damien.ricard@aphp.fr
- Not yet recruiting
AP-HP - Hôpital Henri Mondor
Créteil, 94010
Armand MEKONTSO-DESSAP, Prof, +33 1 49 81 23 91, armand.dessap@aphp.fr
- Not yet recruiting
CH Morlaix
Morlaix, 29672
Pierre-Yves EGRETEAU, Dr, +33 2 98 62 60 95, pyegreteau@ch-morlaix.fr
- Not yet recruiting
CHR Orléans
Orléans, 45067
Mai-Anh NAY, Dr, +33 2 38 57 52 53, mai-anh.nay@chr-orleans.fr
- Not yet recruiting
CH Poitiers
Poitiers, 86000
Jean-Pierre FRAT, Dr, +33 5 49 44 44 44, Jean-pierre.frat@chu-poitiers.fr
- Not yet recruiting
CHU Rennes
Rennes, 35033
Nicolas TERZI, Dr, +33 4 76 76 71 09, nicolas.terzi@chu-rennes.fr
- Not yet recruiting
CHU Tours
Tours, 37044
Pierre-François DEQUIN, Dr, +33 2 47 47 38 55, pierre-francois.dequin@univ-tours.fr
About this study
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:
Read more
"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.
Read the 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.
- Conditions
- Hypoxemic Respiratory Failure
- Being tested
- high flow oxygen therapy rate adjusted of lung volumes measured
- Keywords
- flow oxygen, lung volume, depth camera
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow oxygen therapy rate adjusted of lung volumes measuredDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control arm will consist of patients with hypoxemic respiratory distress treated by high flow oxygen therapy according to standard procedures. |
| interventional | Experimental | 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. Receives: Drug: high flow oxygen therapy rate adjusted of lung volumes measured |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of intubation within 28 days of randomization
Collection of the use of intubation (Yes/No) in patients
Measured: from patient randomization to day 90
Secondary outcomes (7)
Evaluation of organ dysfunction
daily SOFA score
Measured: up to 28 days after randomization
Evaluation of respiratory therapy
daily ROX Index
Measured: up to 28 days after randomization
Reduced need for ventilatory techniques
Number of days without ventilatory support
Measured: from inclusion to day 28
Mortality
Number of death
Measured: 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'.
Measured: 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
Measured: from patient inclusion to day 90
Assessment of patient comfort under high oxygen flow
EVA scale
Measured: up to 28 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start8 Apr 2026
- Primary completionOct 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 406 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819644
- Sponsor's protocol ID
- 29BRC22.0105
- Other IDs
- 2022-A01149-34
- Acronym
- DiStok
- Status last verified
- Jun 2026
- First submitted
- 16 Jan 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No