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

March 30, 2010 updated by: University Hospital, Caen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

1040

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Basse-Normandie
      • Caen, Basse-Normandie, France, 14000
        • University Hospital Caen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
success of intubation at the first attempt
Time Frame: immediately
immediately

Secondary Outcome Measures

Outcome Measure
Time Frame
quality of laryngeal exposition (Cormack and Lehanne modify grade)
Time Frame: immediately
immediately
duration to success intubation
Time Frame: immediately
immediately
Intubation difficult Scale
Time Frame: Immediately
Immediately
result of intubation procedure
Time Frame: immediately
immediately

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Study Director: HANOUZ Jean-Luc, PHD, Anesthesiology critical care SAMU departement, University Hospital of Caen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

April 6, 2009

First Submitted That Met QC Criteria

April 6, 2009

First Posted (Estimate)

April 7, 2009

Study Record Updates

Last Update Posted (Estimate)

March 31, 2010

Last Update Submitted That Met QC Criteria

March 30, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Laryngotest
  • N°ID RCB 2007-A00321-52

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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