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

U

University Hospital, Clermont-Ferrand

Status

Completed

Conditions

Intratracheal
Intubation

Treatments

Procedure: Intubation position

Study type

Interventional

Funder types

Other

Identifiers

NCT03339141
CHU-361
2016-A02078-43 (Other Identifier)

Details and patient eligibility

About

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

Full description

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

Interim analysis every 100 patients.

Enrollment

1,000 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,000 participants in 2 patient groups, including a placebo group

supine position
Placebo Comparator group
Description:
Patients are placed in the supine position at 0° from arrival in the room until intubation
Treatment:
Procedure: Intubation position
25° head-up position
Active Comparator group
Description:
Patients are placed in the 25° head-up position (half-seat or whole body proclive) from arrival in the room until intubation.
Treatment:
Procedure: Intubation position

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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