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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A02078-43 | Other Identifier | 2016-A02078-43 |
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Tracheal intubation, particularly before surgery, is traditionally done in supine position. It was shown in the general population and in obese patients in particular, that the pre-oxygenation in a 25° head-up position provided a better efficiency of the pre-oxygenation and an apnea time longer. This position would also allow for better intubation conditions in direct laryngoscopy.
The investigators intend to assess two different patient's intubation position : supine position and 25° head-up position
Randomization assigned in random block, stratification by operator (20 patients per operator, 10 in each group).
Interim analysis every 100 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| supine position | Placebo Comparator | Patients are placed in the supine position at 0° from arrival in the room until intubation |
|
| 25° head-up position | Active Comparator | Patients are placed in the 25° head-up position (half-seat or whole body proclive) from arrival in the room until intubation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intubation position | Procedure | The investigators assess two different patient's intubation position : supine position and 25° head-up position looking at the intubation score (POGO score). |
| Measure | Description | Time Frame |
|---|---|---|
| POGO score | valid score observed by the anesthetist performing intubation at the time of intubation. POGO score means Percentage of Glottic Opening : from 0% (none visualization of the glottic opening, worst result) to 100% (complete visualization of the glottic opening, best result), from the anterior curvature of the vocal cords to the interarytenoid node, between the posterior cartilage | at day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Cormack-Lehane grade | another valid score observed by the anesthetist performing intubation at the time of intubation. It classifies views obtained by direct laryngoscopy based on the structures seen. From 1 (best result) to 4 (worst result). 1 : full view of glottis (POGO 100%) / 2 : partial view of glottis / 3 : only epiglottis seen, none of glottis seen (POGO 0%) / 4 : Neither glottis nor epiglottis seen (POGO 0%). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Etienne BAZIN | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France | |||
| Pôle Santé République |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31685496 | Derived | Falempin AS, Pereira B, Binakdane F, Bazin JE, Smirdec M. Investigator-initiated, multicentre, open-label, two-arm, randomised controlled trial comparing intubating conditions in 25 degrees head-up position and supine: the InSize25 study protocol. BMJ Open. 2019 Nov 3;9(11):e029761. doi: 10.1136/bmjopen-2019-029761. |
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No masking
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| at day 1 |
| Intubation operator's comfort | visual analog scale about the operator's comfort during intubation. It's a subjective score. It's an evaluation of the comfort of the intubation position from 0 to 10, where 0 is a total discomfort, a painful, very uncomfortable position and 10 is an optimal, very comfortable position. | at day 1 |
| Episodes of desaturation and episodes of hypotension | SpO2 <90% or MAP <65mmHg or drop> 20% of the patient's baseline SBP | at ady 1 |
| Mechanical complications of intubation: | laryngeal pain, hoarseness, upper airway trauma | at day 1 |
| Patient height | at the tragus of the ear during intubation. | at day 1 |
| Clermont-Ferrand |
| France |
| Centre Hospitalier Alpes-Léman | Contamine-sur-Arve | France |
| Polyclinique Saint Odilon | Moulins | 03000 | France |
| Hôpital Saint-Louis / AP-HP | Paris | France |
| Hôpital Nord-Ouest | Villefranche-sur-Saône | France |