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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03339141
Acronym
InSizeS25
Enrollment
1000
Registered
2017-11-13
Start date
2017-11-29
Completion date
2021-09-19
Last updated
2021-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intratracheal, Intubation

Keywords

Intubation conditions, Anaesthetic techniques, Laryngoscopy

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

Detailed description

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

Interventions

PROCEDUREIntubation position

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

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

No masking

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
POGO scoreat day 1valid 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

MeasureTime frameDescription
Cormack-Lehane gradeat day 1another 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%).
Intubation operator's comfortat day 1visual 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.
Episodes of desaturation and episodes of hypotensionat ady 1SpO2 \<90% or MAP \<65mmHg or drop\> 20% of the patient's baseline SBP
Mechanical complications of intubation:at day 1laryngeal pain, hoarseness, upper airway trauma
Patient heightat day 1at the tragus of the ear during intubation.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026