InSizeS25: Comparison of Intubating Conditions in 25° Head-up Position and Strict Supine
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Randomization assigned in random block, stratification by operator (20 patients per operator, 10 in each group).
Interim analysis every 100 patients.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: supine position Patients are placed in the supine position at 0° from arrival in the room until intubation |
Procedure: Intubation position
The investigators assess two different patient's intubation position : supine position and 25° head-up position looking at the intubation score (POGO score).
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| Active Comparator: 25° head-up position Patients are placed in the 25° head-up position (half-seat or whole body proclive) from arrival in the room until intubation. |
Procedure: Intubation position
The investigators assess two different patient's intubation position : supine position and 25° head-up position looking at the intubation score (POGO score).
|
Outcome Measures
Primary Outcome Measures
- POGO score [at day 1]
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
Secondary Outcome Measures
- Cormack-Lehane grade [at day 1]
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%).
- Intubation operator's comfort [at day 1]
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.
- Episodes of desaturation and episodes of hypotension [at ady 1]
SpO2 <90% or MAP <65mmHg or drop> 20% of the patient's baseline SBP
- Mechanical complications of intubation: [at day 1]
laryngeal pain, hoarseness, upper airway trauma
- Patient height [at day 1]
at the tragus of the ear during intubation.
Eligibility Criteria
Criteria
Inclusion Criteria:
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- patients scheduled for various surgeries requiring general anesthesia with curare, with intubation of the trachea, eligible for intubation by direct laryngoscopy.
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18 years
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patients with social security
Exclusion Criteria:
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Emergency surgery.
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Patient who requiring rapid sequence induction.
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Intubation without curare.
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Expected difficult intubation with planned modification of the intubation protocol (i.
- intubation under fibroscopy, airtrach or videolaryngoscopy)
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Patient with a history of epilepsy, pulmonary or cardiovascular disease (including ischemic heart disease, symptomatic asthma or obstructive pulmonary disease).
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Patient with mask phobia.
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BMI> 30kg / m2
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Patient who are refusing to take part.
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Patient protected major, minor, pregnant women, patients deemed incapable of giving informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Clermont-Ferrand | Clermont-Ferrand | France | 63003 | |
| 2 | Pôle Santé République | Clermont-Ferrand | France | ||
| 3 | Centre Hospitalier Alpes-Léman | Contamine-sur-Arve | France | ||
| 4 | Polyclinique Saint Odilon | Moulins | France | 03000 | |
| 5 | Hôpital Saint-Louis / AP-HP | Paris | France | ||
| 6 | Hôpital Nord-Ouest | Villefranche-sur-Saône | France |
Sponsors and Collaborators
- University Hospital, Clermont-Ferrand
Investigators
- Principal Investigator: Jean-Etienne BAZIN, University Hospital, Clermont-Ferrand
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CHU-361
- 2016-A02078-43