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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
  Purpose

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.


Condition Intervention Phase
Intubation
 Device: metallic single use blade
Device: plastic single use blade
Device: metallic reusable blade
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Comparison of Performance of Three Laryngoscope Blades: Plastic Single Use, Metallic Single Use and Metallic Reusable Blades.

Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • success of intubation at the first attempt [ Time Frame: immediately ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1040
Study Start Date: January 2008
Study Completion Date: February 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
metallic single use blade
 Device: metallic single use blade
metallic single use blade
Experimental: 2
plastic single use blade
 Device: plastic single use blade
plastic single use blade
Active Comparator: 3
metallic reusable blade
 Device: metallic reusable blade
metallic reusable blade

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876967

Locations
France
University Hospital Caen
Caen, Basse-Normandie, France, 14000
Sponsors and Collaborators
University Hospital, Caen
Investigators
Study Director: HANOUZ Jean-Luc, PHD Anesthesiology critical care SAMU departement, University Hospital of Caen
  More Information

No publications provided by University Hospital, Caen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hanouz JL PHD, University Hospital, Caen
ClinicalTrials.gov Identifier: NCT00876967     History of Changes
Other Study ID Numbers: Laryngotest, N°ID RCB 2007-A00321-52
Study First Received: April 6, 2009
Last Updated: March 30, 2010
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences
France: French Data Protection Authority

Keywords provided by University Hospital, Caen:
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

ClinicalTrials.gov processed this record on May 23, 2013