Optimisation of High Flow Oxygen Therapy Settings During Hypoxaemic Respiratory Distress Based on Non-contact Measurement of Lung Volumes by Depth Camera
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: high flow oxygen therapy rate adjusted of lung volumes measured.
- Who it may be relevant to
- Registry conditions: Hypoxemic Respiratory Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
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.
Interventions
- Drug 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.
Primary outcome measures
- Use of intubation within 28 days of randomization [Time frame: from patient randomization to day 90]
Secondary outcome measures (7)
- Evaluation of organ dysfunction [Time frame: up to 28 days after randomization]
- Evaluation of respiratory therapy [Time frame: up to 28 days after randomization]
- Reduced need for ventilatory techniques [Time frame: from inclusion to day 28]
- Mortality [Time frame: 90 days after inclusion]
- Collection of data on clinicians' acceptance of the technique and on ergonomics [Time frame: from patient inclusion to day 90]
- Collection of data on clinicians' acceptance of the technique and on ergonomics [Time frame: from patient inclusion to day 90]
- Assessment of patient comfort under high oxygen flow [Time frame: up to 28 days after randomization]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 8 centers
- 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
Identifiers
NCT: NCT06819644 · 29BRC22.0105 · 2022-A01149-34