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

NCT06819644 | Not Yet Recruiting Phase 3

• 2 other identifiers: 29BRC22.01052022-A01149-34
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 7

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.

Conditions

Hypoxemic Respiratory Failure

Keywords

flow oxygen; lung volume; depth camera

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Evaluation of organ dysfunction

  up to 28 days after randomization

• Evaluation of respiratory therapy

  up to 28 days after randomization

• Reduced need for ventilatory techniques

  from inclusion to day 28

• Mortality

  90 days after inclusion

• Collection of data on clinicians' acceptance of the technique and on ergonomics

  from patient inclusion to day 90

Study Arms (2)

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.

Drug: high flow oxygen therapy rate adjusted of lung volumes measured

Interventions

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.

interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patient under legal protection or deprived of liberty

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (7)

AP-HP - Hôpital Louis Mourier

Colombes, 92700, France

Location

AP-HP - Hôpital Henri Mondor

Créteil, 94010, France

Location

CH Morlaix

Morlaix, 29672, France

Location

CHR Orléans

Orléans, 45067, France

Location

CH Poitiers

Poitiers, 86000, France

Location

CHU Rennes

Rennes, 35033, France

Location

CHU Tours

Tours, 37044, France

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Laetitia BODENES, Dr

CONTACT

+33 2 30 33 76 78; laetitia.bodenes@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: February 11, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: February 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)