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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00925665
Other study ID # OdoAbGldscp
Secondary ID
Status Completed
Phase N/A
First received June 19, 2009
Last updated June 27, 2011
Start date January 2009
Est. completion date June 2011

Study information

Verified date June 2009
Source Kliniken Essen-Mitte
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
Glidescope
Patients are to be intubated using the Glidescope technique
Macintosh laryngoscope
Patients are to be intubated using direct laryngoscopy with a Macintosh laryngoscope

Locations

Country Name City State
Germany Kliniken Essen-Mitte Essen

Sponsors (1)

Lead Sponsor Collaborator
Kliniken Essen-Mitte

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Arné J, Descoins P, Fusciardi J, Ingrand P, Ferrier B, Boudigues D, Ariès 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Success rate of endotracheal intubation 18 months No
Secondary Time for intubation 18 months No
Secondary View of the laryngeal entrance (according to the classification of Cormack and Lehane) 18 months No