Hypoxemic Respiratory Failure
Conditions
Keywords
flow oxygen, lung volume, depth camera
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.
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
DRUGhigh 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.
Sponsors
University Hospital, Brest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of intubation within 28 days of randomization | from patient randomization to day 90 | Collection of the use of intubation (Yes/No) in patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of organ dysfunction | up to 28 days after randomization | daily SOFA score |
| Evaluation of respiratory therapy | up to 28 days after randomization | daily ROX Index |
| Reduced need for ventilatory techniques | from inclusion to day 28 | Number of days without ventilatory support |
| Mortality | 90 days after inclusion | Number of death |
| Collection of data on clinicians' acceptance of the technique and on ergonomics | from patient inclusion to day 90 | Evaluation of ergonomy by the System Usability Scale (SUS). The SUS is based on a Likert scale that allows the user to respond on a 5-point scale from 1:'Strongly disagree' to 5:'Strongly agree'. |
| Assessment of patient comfort under high oxygen flow | up to 28 days after randomization | EVA scale |
Countries
France
Contacts
CONTACTLaetitia BODENES, Dr
Outcome results
None listed