NCT00925665

Brief Summary

This study is a comparison of two techniques for endotracheal intubation (Glidescope versus Macintosh) in patients with odontogenic abscesses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

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, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 28, 2011

Status Verified

June 1, 2009

Enrollment Period

2.2 years

First QC Date

June 19, 2009

Last Update Submit

June 27, 2011

Conditions

Odontogenic Abscess

Keywords

IntubationGlidescopeMacintoshAbscessDifficult intubations in patients with odontogenic abscesses

Outcome Measures

Primary Outcomes (1)

  • Success rate of endotracheal intubation

    18 months

Secondary Outcomes (2)

  • Time for intubation

    18 months

  • View of the laryngeal entrance (according to the classification of Cormack and Lehane)

    18 months

Study Arms (2)

Glidescope

Patients intubated with the Glidescope technique

Device: Glidescope

Macintosh

Patients intubated via the conventional direct laryngoscopy with a Macintosh laryngoscope

Device: Macintosh laryngoscope

Interventions

GlidescopeDEVICE

Patients are to be intubated using the Glidescope technique

Glidescope
Macintosh laryngoscopeDEVICE

Patients are to be intubated using direct laryngoscopy with a Macintosh laryngoscope

Macintosh

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We want to study patients, who present with a odontogenic abscess for surgical treatment.

You may qualify if:

  • Patients have to have an abscess which has to be treated surgically.
  • Mouth opening (Inter-incisor gap) has to be less than 3.5 cm and more than 1.4 cm.

You may not qualify if:

  • Age under 18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kliniken Essen-Mitte

Essen, 45136, Germany

Location

Related Publications (1)

  • Arne J, Descoins P, Fusciardi J, Ingrand P, Ferrier B, Boudigues D, Aries J. Preoperative assessment for difficult intubation in general and ENT surgery: predictive value of a clinical multivariate risk index. Br J Anaesth. 1998 Feb;80(2):140-6. doi: 10.1093/bja/80.2.140.

    PMID: 9602574BACKGROUND

MeSH Terms

Conditions

Abscess

Condition Hierarchy (Ancestors)

SuppurationInfectionsInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Harald Groeben, M.D.

    Kliniken Essen-Mitte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 19, 2009

First Posted

June 22, 2009

Study Start

January 1, 2009

Primary Completion

March 1, 2011

Study Completion

June 1, 2011

Last Updated

June 28, 2011

Record last verified: 2009-06

Locations

DE(1)