Clinical trial NCT03339141: Comparison of Intubating Conditions in 25° Head-up Position and Strict Supine
Official title: Comparison of Intubating Conditions in 25° Head-up Position and Strict Supine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Intratracheal
Keywords: Intubation conditions
Anaesthetic techniques
Laryngoscopy
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: POGO score
timeFrame: at day 1
Secondary outcomes:
measure: Cormack-Lehane grade
timeFrame: at day 1
measure: Intubation operator's comfort
timeFrame: at day 1
measure: Episodes of desaturation and episodes of hypotension
timeFrame: at ady 1
measure: Mechanical complications of intubation:
timeFrame: at day 1
measure: Patient height
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Clermont-Ferrand
country: France
facility: Pôle Santé République
city: Contamine-sur-Arve
country: France
facility: Centre Hospitalier Alpes-Léman
city: Moulins
country: France
facility: Polyclinique Saint Odilon
city: Paris
country: France
facility: Hôpital Saint-Louis / AP-HP
city: Villefranche-sur-Saône
country: France
facility: Hôpital Nord-Ouest
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Jean-Etienne BAZIN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.