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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A01419-32 | Other Identifier | ID-RCB Number |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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This randomised study aims to compare the utilization of high-flow humidified nasal oxygenation (HFNO) with standard care, using apnoeic facemask oxygenation, during rapid sequence induction (RSI) of anesthesia in young children.
170 children aged less then 11 years, admitted to the operating room for surgery and with a medical indication of a RSI of anesthesia will be recruited in one university hospital (Necker-Enfants-Malades in Paris).
Children will be randomly assigned into two groups: the control group will benefit of standard care and the HFNO group will receive heated and humidified oxygen through a nasal cannula device during pre-oxygenation and apnoea time prior to tracheal intubation.
HFNO has been evaluated and showed benefits in rapid sequence induction of anesthesia in adults and prolonged apnea time before desaturation in children. To the investigators' knowledge the potential benefit of HFNO during RSI in young children remain to be evaluated.
Hypoxic events during rapid sequence induction (RSI) in children remain more frequent than during standard induction. Although the exact incidence is difficult to appreciate. However the deleterious consequences of hypoxemia during tracheal intubation procedures are well known.
HFNO is an effective technique to supplement oxygen including during apnoea. Studies in children have shown benefits both during breathing and apneic situation.
A monocentric controlled randomized study including children, aged less then 11 years, will be conducted in order to assess the potential benefits of this technique during RSI. The rate of successful tracheal intubation without oxygen desaturation is the primary outcome.
Children will be randomly assigned into two groups:
Adverse events will be recorded and follow-up continued until discharge from the post anesthesia care unit (PACU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OHD (HFNO) | Experimental | High flow nasal oxygen |
|
| Control | Other | Classic pre-oxygenation with facemask |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optiflow - HFNO | Procedure | Pre-oxygenation: HFNO with a 2 L/Kg/min flow during 2 min with 100% FiO2 Oxygenation: during the tracheal intubation, HFNO with a 2 L/Kg/min flow during 2 min with 100% FiO2 |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation without oxygen desaturation episode | Intubation without oxygen desaturation episode, defined as pulsed oxymetry <95% during the rapid sequence induction process of anesthesia in the operating room. | Up to 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen saturation level | Measurement of the lowest oxygen saturation during the tracheal intubation process | Up to 10 minutes |
| Tracheal intubation without facemask reventilation | Tracheal intubation without facemask reventilation |
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Inclusion Criteria:
Exclusion Criteria
- child having one or more contraindication to use high flow nasal oxygenation:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles ORLIAGUET, MD, PhD | Assistance Publique - Hôpitaux de Paris | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Necker - Enfants malades | Paris | 75015 | France |
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| ID | Term |
|---|---|
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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| Classic | Procedure | Pre-oxygenation: with facemask during 2 min with 100% FiO2, flow 6 to 8L/min. No oxygenation during the tracheal intubation |
|
| Up to 10 minutes |
| Number of attempted tracheal intubations required to succeed the process | Number of attempted tracheal intubations required to succeed the process | Up to 10 minutes |
| Occurrence of all adverse events | Occurrence of all adverse events during tracheal intubation in the operating room (linked or not to the use of HFNO) | until the exit of the recovery room |
| Satisfaction of the anaesthetist and the anaesthesia team regarding the use of HFNO | Questionnaire about satisfaction, the use of the procedure, stress level and potential genes | Exit of the recovery room |