Comparison of Intubating Conditions in 25° Head-up Position and Strict Supine

Not Applicable

Completed

• Conditions: Intratracheal; Intubation
• Interventions: Procedure: Intubation position

• Registration Number: NCT03339141
• Lead Sponsor: University Hospital, Clermont-Ferrand

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

Detailed Description

Randomization assigned in random block, stratification by operator (20 patients per operator, 10 in each group).

Interim analysis every 100 patients.

Study Timeline

• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-13
• Study Start: 2017-11-29
• Primary Completion: 2021-09-18
• Study Completion: 2021-09-19
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-21
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
25° head-up position	Intubation position	Patients are placed in the 25° head-up position (half-seat or whole body proclive) from arrival in the room until intubation.
supine position	Intubation position	Patients are placed in the supine position at 0° from arrival in the room until intubation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (6)

Pôle Santé République; 🇫🇷 Clermont-Ferrand, France

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Hôpital Nord-Ouest; 🇫🇷 Villefranche-sur-Saône, France

Centre Hospitalier Alpes-Léman; 🇫🇷 Contamine-sur-Arve, France

Polyclinique Saint Odilon; 🇫🇷 Moulins, France

Hôpital Saint-Louis / AP-HP; 🇫🇷 Paris, France