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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT00876967
First received: April 6, 2009
Last updated: March 30, 2010
Last verified: March 2010
History of Changes

April 6, 2009
March 30, 2010
January 2008
January 2010   (final data collection date for primary outcome measure)
success of intubation at the first attempt [ Time Frame: immediately ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00876967 on ClinicalTrials.gov Archive Site
  • quality of laryngeal exposition (Cormack and Lehanne modify grade) [ Time Frame: immediately ] [ Designated as safety issue: Yes ]
  • duration to success intubation [ Time Frame: immediately ] [ Designated as safety issue: Yes ]
  • Intubation difficult Scale [ Time Frame: Immediately ] [ Designated as safety issue: Yes ]
  • result of intubation procedure [ Time Frame: immediately ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Comparison of Three Laryngoscope Blades for Orotracheal Intubation in the Operating Room
Comparison of Performance of Three Laryngoscope Blades: Plastic Single Use, Metallic Single Use and Metallic Reusable Blades.

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.

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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Intubation
  • Device: metallic single use blade
    metallic single use blade
  • Device: plastic single use blade
    plastic single use blade
  • Device: metallic reusable blade
    metallic reusable blade
  • Experimental: 1
    metallic single use blade
    Intervention: Device: metallic single use blade
  • Experimental: 2
    plastic single use blade
    Intervention: Device: plastic single use blade
  • Active Comparator: 3
    metallic reusable blade
    Intervention: Device: metallic reusable blade
Buléon C, Parienti JJ, Lesage A, Grandin W, Pouliquen E, Flais F, Simonet T, Gérard 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1040
February 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00876967
Laryngotest, N°ID RCB 2007-A00321-52
Yes
Hanouz JL PHD, University Hospital, Caen
University Hospital, Caen
Not Provided
Study Director: HANOUZ Jean-Luc, PHD Anesthesiology critical care SAMU departement, University Hospital of Caen
University Hospital, Caen
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP