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

• ClinicalTrials.gov Identifier: NCT03339141
• Recruitment Status: Completed
• First Posted: November 13, 2017
• Last Update Posted: October 22, 2021
• Sponsor: University Hospital, Clermont-Ferrand
• Information provided by (Responsible Party): University Hospital, Clermont-Ferrand

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
Intubation; Intratracheal	Procedure: Intubation position	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: No masking
• Primary Purpose: Treatment
• Official Title: Comparison of Intubating Conditions in 25° Head-up Position and Strict Supine
• Actual Study Start Date: November 29, 2017
• Actual Primary Completion Date: September 18, 2021
• Actual Study Completion Date: September 19, 2021

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).
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 :

1. POGO score [ Time Frame: 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 :

1. Cormack-Lehane grade [ Time Frame: 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%).
2. Intubation operator's comfort [ Time Frame: 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.
3. Episodes of desaturation and episodes of hypotension [ Time Frame: at ady 1 ]
   SpO2 <90% or MAP <65mmHg or drop> 20% of the patient's baseline SBP
4. Mechanical complications of intubation: [ Time Frame: at day 1 ]
   laryngeal pain, hoarseness, upper airway trauma
5. Patient height [ Time Frame: at day 1 ]
   at the tragus of the ear during intubation.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

France

CHU Clermont-Ferrand

Clermont-Ferrand, France, 63003

Pôle Santé République

Clermont-Ferrand, France

Centre Hospitalier Alpes-Léman

Contamine-sur-Arve, France

Polyclinique Saint Odilon

Moulins, France, 03000

Hôpital Saint-Louis / AP-HP

Paris, France

Hôpital Nord-Ouest

Villefranche-sur-Saône, France

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Investigators

• Principal Investigator: Jean-Etienne BAZIN; University Hospital, Clermont-Ferrand

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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° head-up position and supine: the InSize25 study protocol. BMJ Open. 2019 Nov 3;9(11):e029761. doi: 10.1136/bmjopen-2019-029761.

• Responsible Party: University Hospital, Clermont-Ferrand
• ClinicalTrials.gov Identifier: NCT03339141
• Other Study ID Numbers: CHU-361; 2016-A02078-43 ( Other Identifier: 2016-A02078-43 )
• First Posted: November 13, 2017
• Last Update Posted: October 22, 2021
• Last Verified: October 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Clermont-Ferrand:

Intubation conditions; Anaesthetic techniques; Laryngoscopy

Additional relevant MeSH terms:

Disease; Pathologic Processes