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Oro-tracheal intubation in intensive unit care(ICU) in acute hypoxemic respiratory failure after crash induction remains a critical event.
The aim of this study is to determine whether Nasal High Flow Therapy (HFT) Optiflow ® is more efficient than the face mask for preoxygenation before orotracheal intubation after crash induction in acute hypoxemic respiratory failure
This study will be designed as followed : Patients will be randomized in 2 groups :"PREOXYFLOW" or "STANDARD FACE MASK".
Patients randomized in "PREOXYFLOW" group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) (60 l/mn FIO2 = 1) before orotracheal intubation under laryngoscopy after crash induction. Patients randomized in "STANDARD FACE MASK" group will received a four minutes preoxygenation period with standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PREOXYFLOW | Experimental | Patients randomized in "PREOXYFLOW" group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) Optiflow ® (60 l/mn FIO2 = 1) before orotracheal intubation under laryngoscopy after crash induction |
|
| STANDARD FACE MASK | Active Comparator | Patients randomized in "STANDARD FACE MASK" group will received a four minutes preoxygenation period with a standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction. No specific trademark is requested by the protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PREOXYFLOW | Device | Patients randomized in "PREOXYFLOW" group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) Optiflow ® (60 l/mn FIO2 = 1) before orotracheal intubation under laryngoscopy after crash induction |
| Measure | Description | Time Frame |
|---|---|---|
| to determine whether Optiflow® used during the preoxygenation period before orotracheal intubation after crash induction is more efficient than standard face mask. | This outcome will be assessed from the beginning of the preoxygenation period to the end of orotracheal intubation by monitoring the pulse oxymetry | 4 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of quality of preoxygenation | 4 minutes | |
| Reduction in side effects incidence related to intubation | 1 hour | |
| Reduction in Organ failure in the 5th day |
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Inclusion Criteria:
Respiratory rate > 30/mn AND Hypoxemia with SpO2 <90% with oxygen supply > FiO2 0,5 AND PaO2/FiO2 <300 mmHg
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes Universitary Hospital, medical intensive care unit | Nantes | Loire Atlantique | 44093 | France | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25869405 | Derived | Vourc'h M, Asfar P, Volteau C, Bachoumas K, Clavieras N, Egreteau PY, Asehnoune K, Mercat A, Reignier J, Jaber S, Prat G, Roquilly A, Brule N, Villers D, Bretonniere C, Guitton C. High-flow nasal cannula oxygen during endotracheal intubation in hypoxemic patients: a randomized controlled clinical trial. Intensive Care Med. 2015 Sep;41(9):1538-48. doi: 10.1007/s00134-015-3796-z. Epub 2015 Apr 14. |
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| STANDARD FACE MASK | Procedure | Patients randomized in "STANDARD FACE MASK" group will received a four minutes preoxygenation period with a standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction. Each hospital involved in this study will use the standard face mask as per its usual practice (no specific trademark requested by this protocol) |
|
| at day 5 |
| Reduction in morbi-mortality during the Intensive Care Unit stay. | until day 28 OR, if patient still in the intensive care unit (ICU) at Day 28, until discharge of ICU |
| Angers Universitary Hospital |
| Angers |
| 49933 |
| France |
| Brest Universitary Hospital | Brest | 29609 | France |
| La Roche/Yon Hospital | La Roche/Yon | 85925 | France |
| Montpellier University hospital | Montpellier | 34295 | France |
| Nantes Universitary Hospital, surgical intensive care unit | Nantes | 44093 | France |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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