Comparison of Intubating Conditions in 25° Head-up Position and Strict Supine (InSizeS25)

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

Study Overview

• Status: Completed
• Conditions: Intubation; Intratracheal
• Intervention / Treatment: Procedure: Intubation 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 Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Chu Clermont-Ferrand
  • Clermont-Ferrand, France
    • Pôle Santé République
  • Contamine-sur-Arve, France
    • Centre Hospitalier Alpes-Léman
  • Moulins, France, 03000
    • Polyclinique Saint Odilon
  • Paris, France
    • Hôpital Saint-Louis / AP-HP
  • Villefranche-sur-Saône, France
    • Hôpital Nord-Ouest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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).
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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%).	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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2017
• Primary Completion (Actual): September 18, 2021
• Study Completion (Actual): September 19, 2021

Study Registration Dates

• First Submitted: November 8, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (Actual): November 13, 2017

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Laryngoscopy; Intubation conditions; Anaesthetic techniques
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: CHU-361; 2016-A02078-43 (Other Identifier: 2016-A02078-43)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No