Comparison of Three Laryngoscope Blades for Orotracheal Intubation in the Operating Room

NCT ID: NCT00876967

Last Updated: 2010-03-31

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

PHASE4

Total Enrollment

1040 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-02-28

Brief Summary

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The purpose of this study is to determinate if there is a difference in performance provided by three laryngoscope blades: plastic single use, metallic single use and metallic reusable blades.

Detailed Description

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Primary outcome: success of intubation at the first attempt

Secondary outcomes: quality of laryngeal exposition (Cormack and Lehanne modify grade), duration to success intubation, Intubation difficult Scale and result of intubation procedure

Conditions

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Intubation

Keywords

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anesthesiology randomized laryngoscope intubation laryngeal exposition laryngoscope blades plastic single use blade metallic single use blade metallic reusable blade success to intubation at first attempt Cormack and lehanne modify grade

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1

metallic single use blade

Group Type EXPERIMENTAL

metallic single use blade

Intervention Type DEVICE

metallic single use blade

2

plastic single use blade

Group Type EXPERIMENTAL

plastic single use blade

Intervention Type DEVICE

plastic single use blade

3

metallic reusable blade

Group Type ACTIVE_COMPARATOR

metallic reusable blade

Intervention Type DEVICE

metallic reusable blade

Interventions

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metallic single use blade

metallic single use blade

Intervention Type DEVICE

plastic single use blade

plastic single use blade

Intervention Type DEVICE

metallic reusable blade

metallic reusable blade

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patient age over 18 who need general anesthesia with orothracheal intubation

Exclusion Criteria

* patient age under 18 or major assist
* presence of upper airway malformation or abnormality
* cervical or facial trauma
* previous difficult intubation known
* no use of curare
* Body Mass Index over 30kg/m2 if crush induction use
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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University Hospital, Caen

Principal Investigators

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HANOUZ Jean-Luc, PHD

Role: STUDY_DIRECTOR

Anesthesiology critical care SAMU departement, University Hospital of Caen

Locations

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University Hospital Caen

Caen, Basse-Normandie, France

Site Status

Countries

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France

References

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Buleon C, Parienti JJ, Lesage A, Grandin W, Pouliquen E, Flais F, Simonet T, Gerard JL, Hanouz JL. Comparison of plastic and metallic single-use and metallic reusable laryngoscope blades: a randomised controlled trial. Eur J Anaesthesiol. 2013 Apr;30(4):163-9. doi: 10.1097/EJA.0b013e32835c1cdb.

Reference Type DERIVED
PMID: 23274619 (View on PubMed)

Other Identifiers

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N°ID RCB 2007-A00321-52

Identifier Type: -

Identifier Source: secondary_id

Laryngotest

Identifier Type: -

Identifier Source: org_study_id