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

NCT ID: NCT03339141

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-29

Study Completion Date

2021-09-19

Brief Summary

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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

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

Interim analysis every 100 patients.

Conditions

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Intubation Intratracheal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No masking

Study Groups

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supine position

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

Group Type PLACEBO_COMPARATOR

Intubation position

Intervention Type 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

Patients are placed in the 25° head-up position (half-seat or whole body proclive) from arrival in the room until intubation.

Group Type ACTIVE_COMPARATOR

Intubation position

Intervention Type PROCEDURE

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

Interventions

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Intubation position

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Etienne BAZIN

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Pôle Santé République

Clermont-Ferrand, , France

Site Status

Centre Hospitalier Alpes-Léman

Contamine-sur-Arve, , France

Site Status

Polyclinique Saint Odilon

Moulins, , France

Site Status

Hôpital Saint-Louis / AP-HP

Paris, , France

Site Status

Hôpital Nord-Ouest

Villefranche-sur-Saône, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 31685496 (View on PubMed)

Other Identifiers

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2016-A02078-43

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-361

Identifier Type: -

Identifier Source: org_study_id