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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A01098-39 | Other Identifier | ANSM |
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Background : Patient with hypoxemic respiratory failure treated with NIV receive between NIV session oxygen therapy. Gaz exchange disorder with a decrease of the ratio between Partial Pressure of Arterial Oxygen (PaO2) and Inspired Fraction of Oxygen (FIO2) are noticed when NIV is stopped at the end of the session du to alveolar derecruitment Optiflow is a high flow oxygen delivery system used a heated humidifier and heated breathing circuit. In observational studies, Optiflow increase oxygenation of patients with hypoxemic respiratory failure. Oxygenation is better than under high-concentration mask and work of breathing is reduced.
The aim of the study is to compare in acute hypoxemic respiratory failure, optiflow to oxygen therapy under high-concentration mask, on patients oxygenation between NIV sessions (measured as the difference between PaO2/FiO2 ratio at the beginning and at the end of the session), during the first two NIV sessions
Study design : Prospective, randomized, controlled, multicentric, open clinical trial with two groups:
Number of subjects: 100 (50 patients per group) patients admitted in intensive Care Unit for hypoxemic respiratory failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optiflow group | Experimental |
| |
| Control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optiflow | Device | Patients receive high flow oxygen delivery system, Optiflow, conventional clinical management and sequential used of NIV for a period of 36 hours at least. High flow oxygen nasal therapy (Optiflow) : The flow will be set at 40l/min to 60l/min The inspired fraction of oxygen (FiO2) is the same as that defined at the end of VNI session and may be adjusted in order to obtain a SaO2 between 94% and 98%. |
| Measure | Description | Time Frame |
|---|---|---|
| Average of oxygenation differences measured as the delta between PaO2/FiO2ratio at the end of the first ans second NIV session and at the end of the first and second oxygen therapy session. | Average of oxygenation differences measured as the delta between PaO2/FiO2 ratio at the end of the first NIV session and at the end of the first oxygen therapy session (according group of treatment) on the one hand and on the other hand the delta between PaO2/FiO2 ratio at the end of the second NIV session and at the end of the second oxygen thrapy session Five measurements of PaO2/FiO2 ratio are realized with arterial blood gases:
| 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| comfort score dyspnea beetween the two NIV sessions | The comfort score and dyspnea will be assessed between the two NIV sessions | 28 days |
| Incidence of serious adverse events between the two NIV sessions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antoine BENARD, Docotor | University Hospital, Bordeaux | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de réanimation - CH de la côte basque | Bayonne | Aquitaine | 64100 | France | ||
| Service de réanimation médicale - CHU de Bordeaux |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| Conventional oxygen therapy | Device | Patients receive conventional oxygen therapy with high concentration mask, conventional clinical management, and sequential use of NIV Conventional oxygen therapy: The inspired fraction of oxygen (FiO2) is the same as that defined at the end of VNI session and may be adjusted in order to obtain a Arterial Oxygen Saturation (SaO2) between 94% and 98%. |
|
| 28 days |
| Respiratory rate between the two NIV sessions | Respiratory rate to assess work of breathing between the two NIV sessions | 28 days |
| incidence of intubation during the NIV treatment of Acute respiratory distress syndrome (ARDS) | 28 days |
| ICU mortality | 28 days |
| 28 days survival | 28 days |
| Hospital mortality | 28 days |
| ICU length of stay | 28 days |
| duration of mechanical ventilation | 28 days |
| Bordeaux |
| Aquitaine |
| 33000 |
| France |
| Service de Réanimation Polyvalente - CH de Libourne | Libourne | Aquitaine | 33505 | France |
| Service de Réanimation - CH de Perigueux | Périgueux | Aquitiane | 24000 | France |
| Service de Réanimation Polyvalente - CHU de Toulouse | Toulouse | Midi-pyrenees | 31059 | France |
| Service de Réanimation Polyvalente - CH d'Agen | Agen | 47923 | France |
| Réanimation polyvalente - CH d'Albi | Albi | 81000 | France |
| Réanimation Polyvalente - CH de Mont de Marsan | Mont-de-Marsan | 40024 | France |