Intubation Clinical Trial
— InSizeS25Official title:
Comparison of Intubating Conditions in 25° Head-up Position and Strict Supine
Verified date | October 2021 |
Source | University Hospital, Clermont-Ferrand |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 1000 |
Est. completion date | September 19, 2021 |
Est. primary completion date | September 18, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - - patients scheduled for various surgeries requiring general anesthesia with curare, with intubation of the trachea, eligible for intubation by direct laryngoscopy. - > 18 years - patients with social security Exclusion Criteria: - Emergency surgery. - Patient who requiring rapid sequence induction. - Intubation without curare. - Expected difficult intubation with planned modification of the intubation protocol (i. e. intubation under fibroscopy, airtrach or videolaryngoscopy) - Patient with a history of epilepsy, pulmonary or cardiovascular disease (including ischemic heart disease, symptomatic asthma or obstructive pulmonary disease). - Patient with mask phobia. - BMI> 30kg / m2 - Patient who are refusing to take part. - Patient protected major, minor, pregnant women, patients deemed incapable of giving informed consent. |
Country | Name | City | State |
---|---|---|---|
France | CHU Clermont-Ferrand | Clermont-Ferrand | |
France | Pôle Santé République | Clermont-Ferrand | |
France | Centre Hospitalier Alpes-Léman | Contamine-sur-Arve | |
France | Polyclinique Saint Odilon | Moulins | |
France | Hôpital Saint-Louis / AP-HP | Paris | |
France | Hôpital Nord-Ouest | Villefranche-sur-Saône |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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%). | at day 1 | |
Secondary | 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 | |
Secondary | Episodes of desaturation and episodes of hypotension | SpO2 <90% or MAP <65mmHg or drop> 20% of the patient's baseline SBP | at ady 1 | |
Secondary | Mechanical complications of intubation: | laryngeal pain, hoarseness, upper airway trauma | at day 1 | |
Secondary | Patient height | at the tragus of the ear during intubation. | at day 1 |
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