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NCT Number: NCT03339141

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

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

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Key information

Conditions

Intubation Intratracheal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand, Clermont-Ferrand, France

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About this study

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

Interim analysis every 100 patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: InSizeS25

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Nov 13, 2017
Registry last updated
Oct 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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