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

Intubation Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03339141
• Other study ID #: CHU-361
• Secondary ID: 2016-A02078-43
• Status: Completed
• Phase: N/A
• Start date: November 29, 2017
• Est. completion date: September 19, 2021

Study information

• Verified date: October 2021
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Randomization assigned in random block, stratification by operator (20 patients per operator, 10 in each group). Interim analysis every 100 patients.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Disease
• Intratracheal
• Intubation

Intervention

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).

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

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