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

NCT03339141 | Completed

• 2 other identifiers: CHU-3612016-A02078-43
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 6

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

Conditions

Intubation; Intratracheal

Keywords

Intubation conditions; Anaesthetic techniques; Laryngoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Cormack-Lehane grade

  at day 1

• Intubation operator's comfort

  at day 1

• Episodes of desaturation and episodes of hypotension

  at ady 1

• Mechanical complications of intubation:

  at day 1

• Patient height

  at day 1

Study Arms (2)

supine position

PLACEBO COMPARATOR

Patients are placed in the supine position at 0° from arrival in the room until intubation

Procedure: Intubation position

25° head-up position

ACTIVE COMPARATOR

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

Interventions

Intubation position PROCEDURE

The investigators assess two different patient's intubation position : supine position and 25° head-up position looking at the intubation score (POGO score).

25° head-up position; supine position

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (6)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Pôle Santé République

Clermont-Ferrand, France

Location

Centre Hospitalier Alpes-Léman

Contamine-sur-Arve, France

Location

Polyclinique Saint Odilon

Moulins, 03000, France

Location

Hôpital Saint-Louis / AP-HP

Paris, France

Location

Hôpital Nord-Ouest

Villefranche-sur-Saône, France

Location

Related Publications (1)

• 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.

  PMID: 31685496 DERIVED

Study Officials

• Jean-Etienne BAZIN

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 13, 2017
• Study Start: November 29, 2017
• Primary Completion: September 18, 2021
• Study Completion: September 19, 2021
• Last Updated: October 22, 2021

Record last verified: 2021-10

Locations

FR (6)