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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

• Use of intubation within 28 days of randomization [Срок оценки: from patient randomization to day 90]

Вторичные конечные точки (7)

• Evaluation of organ dysfunction [Срок оценки: up to 28 days after randomization]
• Evaluation of respiratory therapy [Срок оценки: up to 28 days after randomization]
• Reduced need for ventilatory techniques [Срок оценки: from inclusion to day 28]
• Mortality [Срок оценки: 90 days after inclusion]
• Collection of data on clinicians' acceptance of the technique and on ergonomics [Срок оценки: from patient inclusion to day 90]
• Collection of data on clinicians' acceptance of the technique and on ergonomics [Срок оценки: from patient inclusion to day 90]
• Assessment of patient comfort under high oxygen flow [Срок оценки: up to 28 days after randomization]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 8 центров

• Brest, University Hospital — Brest
• AP-HP - Hôpital Louis Mourier — Colombes
• AP-HP - Hôpital Henri Mondor — Créteil
• CH Morlaix — Morlaix
• CHR Orléans — Orléans
• CH Poitiers — Poitiers
• CHU Rennes — Rennes
• CHU Tours — Tours

Идентификаторы

NCT: NCT06819644 · 29BRC22.0105 · 2022-A01149-34

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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