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

Regional University Hospital Center (CHRU)

Status and phase: Not yet enrolling; Phase 3

Conditions: Hypoxemic Respiratory Failure

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06819644

2022-A01149-34 (Other Identifier)

29BRC22.0105

Details and patient eligibility

About

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.

Full 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.

Enrollment: 406 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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406 participants in 2 patient groups

Control

No Intervention group

Description:

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

interventional

Experimental group

Description:

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.

Treatment:

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