Intubation of Patients With Odontogenic Abcesses

This study has been completed.
Sponsor:
Information provided by:
Kliniken Essen-Mitte
ClinicalTrials.gov Identifier:
NCT00925665
First received: June 19, 2009
Last updated: June 27, 2011
Last verified: June 2009
  Purpose

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


Condition Intervention
Odontogenic Abscess
Device: Glidescope
Device: Macintosh laryngoscope

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intubation of Patients With Odontogenic Abcesses Glidescope vs. Macintosh Technique

Further study details as provided by Kliniken Essen-Mitte:

Primary Outcome Measures:
  • Success rate of endotracheal intubation [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time for intubation [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • View of the laryngeal entrance (according to the classification of Cormack and Lehane) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2009
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Glidescope
Patients intubated with the Glidescope technique
Device: Glidescope
Patients are to be intubated using the Glidescope technique
Macintosh
Patients intubated via the conventional direct laryngoscopy with a Macintosh laryngoscope
Device: Macintosh laryngoscope
Patients are to be intubated using direct laryngoscopy with a Macintosh laryngoscope

Detailed Description:

Patients with odontogenic abcesses have to be treated by surgical drainage of the abscess under general intubation with endotracheal intubation. Because of a limited mouth opening and swelling within the oral cavity, intubation can be difficult and sometimes impossible with conventional direct laryngoscopy. Therefore, alternative techniques are desirable. We want to compare the success rate of intubation in these patients using the Glidescope technique vs. conventional Macintosh technique.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Age under 18 years.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00925665

Locations
Germany
Kliniken Essen-Mitte
Essen, Germany, 45136
Sponsors and Collaborators
Kliniken Essen-Mitte
Investigators
Principal Investigator: Harald Groeben, M.D. Kliniken Essen-Mitte
  More Information

Publications:
Responsible Party: Prof.Dr. Harald Groeben, Kliniken Essen-Mitte
ClinicalTrials.gov Identifier: NCT00925665     History of Changes
Other Study ID Numbers: OdoAbGldscp
Study First Received: June 19, 2009
Last Updated: June 27, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Kliniken Essen-Mitte:
Intubation
Glidescope
Macintosh
Abscess
Difficult intubations in patients with odontogenic abscesses

Additional relevant MeSH terms:
Abscess
Suppuration
Infection
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on August 01, 2014