NCT00378170

Brief Summary

The primary objective is to evaluate a knewly developed blade (for intubating patients about to undergo surgery) and compare it to the traditional Macintosh blade

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2006

Completed
Last Updated

December 4, 2006

Status Verified

November 1, 2006

First QC Date

September 18, 2006

Last Update Submit

December 1, 2006

Conditions

Anesthesia, Intravenous

Keywords

intubationdifficultyMacintoshdental damagecomplications

Outcome Measures

Primary Outcomes (2)

  • succes rate - immediate evaluation

  • difficulty - immediate evaluation

Secondary Outcomes (4)

  • Cormack & Lehane grading

  • Time to intubate

  • Interincissor gap

  • vissible complication

Interventions

intubation of patients undergoing elective surgeryDEVICE

Eligibility Criteria

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

You may qualify if:

  • age over 18
  • ASA 1-III
  • Patients undergoing elective surgery requering intubation at KAS Herlev

You may not qualify if:

  • Prior difficult intubation indicating awake fiberoptic intubation
  • pathology in the airways predicting difficult intubation
  • columna cervicalis fractures
  • pregnancy
  • Requirement for Rapid sequence induction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KAS Herlev university Hospital

Herlev, Herlev, 2730, Denmark

RECRUITING

Study Officials

  • Ann Møller, consultant

    STUDY DIRECTOR

Central Study Contacts

Ulrik Grevstad, MD

CONTACT

+4525348390basviola@get2net.dk

Ann Møller, MD

CONTACT

+4544884488annmo@herlevhosp.kbhamt.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 18, 2006

First Posted

September 19, 2006

Study Start

January 1, 2006

Last Updated

December 4, 2006

Record last verified: 2006-11

Locations

DK(1)