Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A01149-34 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 :
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Use of intubation within 28 days of randomization | Collection of the use of intubation (Yes/No) in patients | from patient randomization to day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of organ dysfunction | daily SOFA score | up to 28 days after randomization |
| Evaluation of respiratory therapy | daily ROX Index |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laetitia BODENES, Dr | Contact | +33 2 30 33 76 78 | laetitia.bodenes@chu-brest.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brest, University Hospital | Recruiting | Brest | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| up to 28 days after randomization |
| Reduced need for ventilatory techniques | Number of days without ventilatory support | from inclusion to day 28 |
| Mortality | Number of death | 90 days after inclusion |
| Collection of data on clinicians' acceptance of the technique and on ergonomics | 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'. | from patient inclusion to day 90 |
| Collection of data on clinicians' acceptance of the technique and on ergonomics | Evaluation of load task by NASA-TLX index | from patient inclusion to day 90 |
| Assessment of patient comfort under high oxygen flow | EVA scale | up to 28 days after randomization |
| AP-HP - Hôpital Louis Mourier | Not yet recruiting | Colombes | 92700 | France |
|
| AP-HP - Hôpital Henri Mondor | Not yet recruiting | Créteil | 94010 | France |
|
| CH Morlaix | Not yet recruiting | Morlaix | 29672 | France |
|
| CHR Orléans | Not yet recruiting | Orléans | 45067 | France |
|
| CH Poitiers | Not yet recruiting | Poitiers | 86000 | France |
|
| CHU Rennes | Not yet recruiting | Rennes | 35033 | France |
|
| CHU Tours | Not yet recruiting | Tours | 37044 | France |
|
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided