NCT00310999

Brief Summary

Patients undergoing surgery will have laryngoscopy performed using two widely accepted techniques - Macintosh Laryngoscope and Shikani Optical Scope. The techniques will be timed and compared for cervical spine movement using fluoroscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2006

Shorter than P25 for not_applicable

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

March 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 3, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

April 3, 2006

Last Update Submit

November 2, 2018

Conditions

Wounds and Injuries

Keywords

Cervical VertebraeIntubation, IntratrachealLaryngoscopesFluoroscopy

Outcome Measures

Primary Outcomes (1)

  • cervical spine movement

Secondary Outcomes (1)

  • Duration of intubation

Interventions

Shikani Optical StyletDEVICE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective non-cardiac surgery patients requiring intubation for the surgery.
  • Age 18-75
  • ASA 1-3
  • Body Mass Index (BMI) \< 40

You may not qualify if:

  • patients with previous neck surgery or unstable C-spine
  • patients with Reflux disease (GERD)
  • patients who are or may be pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre University Hospital Site

London, Ontario, N6A 5A5, Canada

Location

Related Publications (3)

  • Turkstra TP, Craen RA, Pelz DM, Gelb AW. Cervical spine motion: a fluoroscopic comparison during intubation with lighted stylet, GlideScope, and Macintosh laryngoscope. Anesth Analg. 2005 Sep;101(3):910-915. doi: 10.1213/01.ane.0000166975.38649.27.

    PMID: 16116013BACKGROUND

  • Sawin PD, Todd MM, Traynelis VC, Farrell SB, Nader A, Sato Y, Clausen JD, Goel VK. Cervical spine motion with direct laryngoscopy and orotracheal intubation. An in vivo cinefluoroscopic study of subjects without cervical abnormality. Anesthesiology. 1996 Jul;85(1):26-36. doi: 10.1097/00000542-199607000-00005.

    PMID: 8694378BACKGROUND

  • Watts AD, Gelb AW, Bach DB, Pelz DM. Comparison of the Bullard and Macintosh laryngoscopes for endotracheal intubation of patients with a potential cervical spine injury. Anesthesiology. 1997 Dec;87(6):1335-42. doi: 10.1097/00000542-199712000-00012.

    PMID: 9416718BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Timothy P Turkstra, MD

    London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

  • Rosemary A Craen, MD

    London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

  • David M Pelz, MD

    London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

  • Allison Shakih, MD

    London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2006

First Posted

April 5, 2006

Study Start

March 1, 2006

Primary Completion

June 1, 2006

Study Completion

September 1, 2006

Last Updated

November 6, 2018

Record last verified: 2018-11

Locations

CA(1)