NCT00876967

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,040

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2008

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

March 31, 2010

Status Verified

March 1, 2010

Enrollment Period

2 years

First QC Date

April 6, 2009

Last Update Submit

March 30, 2010

Conditions

Intubation

Keywords

anesthesiologyrandomizedlaryngoscopeintubationlaryngeal expositionlaryngoscope bladesplastic single use blademetallic single use blademetallic reusable bladesuccess to intubation at first attemptCormack and lehanne modify grade

Outcome Measures

Primary Outcomes (1)

  • success of intubation at the first attempt

    immediately

Secondary Outcomes (4)

  • quality of laryngeal exposition (Cormack and Lehanne modify grade)

    immediately

  • duration to success intubation

    immediately

  • Intubation difficult Scale

    Immediately

  • result of intubation procedure

    immediately

Study Arms (3)

1

EXPERIMENTAL

metallic single use blade

Device: metallic single use blade

2

EXPERIMENTAL

plastic single use blade

Device: plastic single use blade

3

ACTIVE COMPARATOR

metallic reusable blade

Device: metallic reusable blade

Interventions

metallic single use bladeDEVICE

metallic single use blade

1
plastic single use bladeDEVICE

plastic single use blade

2
metallic reusable bladeDEVICE

metallic reusable blade

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Caen

Caen, Basse-Normandie, 14000, France

Location

Related Publications (1)

  • 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.

    PMID: 23274619DERIVED

Study Officials

  • HANOUZ Jean-Luc, PHD

    Anesthesiology critical care SAMU departement, University Hospital of Caen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 6, 2009

First Posted

April 7, 2009

Study Start

January 1, 2008

Primary Completion

January 1, 2010

Study Completion

February 1, 2010

Last Updated

March 31, 2010

Record last verified: 2010-03

Locations

FR(1)