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

NCT ID: NCT06819644

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

406 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-28

Study Completion Date

2029-05-31

Brief Summary

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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

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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

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Hypoxemic Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

The control arm will consist of patients with hypoxemic respiratory distress treated by high flow oxygen therapy according to standard procedures.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

high flow oxygen therapy rate adjusted of lung volumes measured

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AP-HP - Hôpital Louis Mourier

Colombes, , France

Site Status

AP-HP - Hôpital Henri Mondor

Créteil, , France

Site Status

CH Morlaix

Morlaix, , France

Site Status

CHR Orléans

Orléans, , France

Site Status

CH Poitiers

Poitiers, , France

Site Status

CHU Rennes

Rennes, , France

Site Status

CHU Tours

Tours, , France

Site Status

Countries

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France

Central Contacts

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Laetitia BODENES, Dr

Role: CONTACT

+33 2 30 33 76 78

Facility Contacts

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Jean-Damien RICARD, Prof

Role: primary

+33 1 47 60 61 91

Armand MEKONTSO-DESSAP, Prof

Role: primary

+33 1 49 81 23 91

Pierre-Yves EGRETEAU, Dr

Role: primary

+33 2 98 62 60 95

Mai-Anh NAY, Dr

Role: primary

+33 2 38 57 52 53

Jean-Pierre FRAT, Dr

Role: primary

+33 5 49 44 44 44

Nicolas TERZI, Dr

Role: primary

+33 4 76 76 71 09

Pierre-François DEQUIN, Dr

Role: primary

+33 2 47 47 38 55

Other Identifiers

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2022-A01149-34

Identifier Type: OTHER

Identifier Source: secondary_id

29BRC22.0105

Identifier Type: -

Identifier Source: org_study_id

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