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High-flow nasal oxygen therapy (HFNO) is an oxygenation technique frequently used in intensive care.
The main objective of our study is to show that the use of a protocol for weaning patients off high-flow nasal oxygen therapy (HFNO) in the intensive care unit increases the probability that patients will be weaned from HFNO at Day 7 post-randomisation.
This is a open-label multicentre randomised controlled trial conducted in two parallel groups.
The primary endpoint is the success rate at Day 7, with success defined as "definitive" weaning from HFNO, i.e. patients weaned from HFNO for more than 48 hours without recourse to non-invasive ventilation (NIV) or intubation and still alive at Day 7.
The weaning protocol will be started as soon as the patient meets all the inclusion criteria, considered to be the prerequisites for initiating weaning from HFNO. Patients will be monitored until Day 28 maximum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group : Imposed weaning protocol | Experimental | The flow of the HFNO will remain high (50-60 L/min) guaranteeing the effectiveness of the HFNO on the wash-out of the anatomical space. At the same time, weaning will begin with a gradual reduction in FiO2 of 0.1 every 4 hours. To achieve this reduction, the patient will have to meet the safety targets of a stable respiratory rate at rest (no increase) and pulsed oxygen saturation (SpO2). The SpO2 target will be 92-95%. Once the FiO2 has stabilised at 0.4 for 4 hours, the nurse will initiate a 10 L/min reduction in the flow of HFNO every 4 hours. The oxygen therapy support may be changed for standard oxygen when the HFNO flow rate is 40L/min with an FIO2 of 0.4 for 4 consecutive hours. |
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| Control group | Active Comparator | Weaning methods will be left to the free choice of the practitioner. Any change in the HFNO setting must be made on medical prescription. A minimum SpO2 objective is required (SpO2 ≥92%). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HFNO weaning protocol | Drug | Algorithm based on SpO2 values and respiratory rate: a decrease of FiO2 and of the flow will be done |
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| Measure | Description | Time Frame |
|---|---|---|
| The success rate at Day 7 | Success being defined as "definitive" weaning from HFNO, i.e. a patient weaned for more than 48 hours from HFNO without recourse to non-invasive ventilation or intubation and still alive at Day 7. | At day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| High-flow nasal oxygen therapy (HFNO) weaning rate at day 28 | At day 28 | |
| Time to definitive weaning from HFNO | From randomisation to day 28 | |
| Cumulative incidence of intubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mai-Anh NAY, MD | Contact | 02.38.51.44.46 | +33 | mai-anh.nay@chr-orleans.fr |
| Marie LECLERC | Contact | 02.47.47.46.64 | +33 | m.leclerc@chu-tours.fr |
| Name | Affiliation | Role |
|---|---|---|
| Mai-Anh NAY, MD | CHRU Orléans | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive care, University Hospital, Blois | Recruiting | Blois | France |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| HFNO Standard of care | Drug | Weaning methods will be left to the free choice of the practitioner. |
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| From randomisation to day 28 |
| Cumulative incidence of use of curative non-invasive ventilation | From randomisation to day 28 |
| Mortality rate at day 28 | At Day 28 |
| Number of days on HFNO for patients definitively weaned from HFNO | From randomisation to discharge from intensive care or at Day 28 |
| Changes in the ROX index during the weaning phase | ROX index : [(SpO2/FiO2)/respiratory rate] | From randomisation to day 28 |
| Changes in the use of accessory respiratory muscles | Using the Patrick score (Score from 0 to 5) | From randomisation to discharge from intensive care or to Day 28 |
| Progression of dyspnoea | Assessed by the modified Borg scale (scale from 0 to 10) | From randomisation to discharge from intensive care or to Day 28 |
| Intensive care unit and/or continuous monitoring unit length of stay | From randomization until the date of discharge, assessed up to 28 days maximum |
| Intensive care unit and/or continuous monitoring unit length of stay or time to ICU discharge readiness | The ability to go out will be defined by the validation of all the items on the modified ability grid (score modified from Hiller et al. ; 28 items) | From randomization until the date of discharge OR ability to be discharged from intensive care, assessed up to 28 days maximum |
| Intensive care unit, University Hospital, Bourg-en-Bresse | Recruiting | Bourg-en-Bresse | France |
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| Intensive care, University Hospital, Bourges | Recruiting | Bourges | France |
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| Intensive care unit, University Hospital, Caen | Not yet recruiting | Caen | France |
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| Intensive care, University Hospital, Chartres | Recruiting | Chartres | France |
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| Intensive care, University Hospital, Cholet | Recruiting | Cholet | France |
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| Intensive care, University Hospital, Dax | Recruiting | Dax | France |
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| Intensive care, University Hospital, Le Mans, | Recruiting | Le Mans | France |
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| Intensive care, University Hospital, Orléans | Recruiting | Orléans | France |
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| Intensive care, University Hospital, Tours | Recruiting | Tours | France |
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| Intensive care unit, University Hospital, Vannes | Recruiting | Vannes | France |
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