Maintaining the Head Extension by an Assistant Decreases Dental Contact

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01427348
First received: August 30, 2011
Last updated: May 28, 2012
Last verified: May 2012
  Purpose

The purpose of this study is to determine whether the head extension by an assistant decreases dental contact between laryngoscope blade and maxillary incisors during direct laryngoscopy


Condition Intervention
Dental Contact During Direct Laryngoscopy
Procedure: with assistant
Procedure: without assistant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Maintaining the Head Extension by an Assistant Decreases Dental Contact Between Laryngoscope Blade and Maxillary Incisors During Direct Laryngoscopy

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • dental contact [ Time Frame: up to 10 minutes ] [ Designated as safety issue: Yes ]
    dental contact between laryngoscope blade and maxillary incisors


Secondary Outcome Measures:
  • teeth distance [ Time Frame: up to 10 minutes ] [ Designated as safety issue: Yes ]
    teeth distance between laryngoscope blade and maxillary incisors


Enrollment: 68
Study Start Date: September 2011
Study Completion Date: May 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: with assistant
head extension by an assistant during direct laryngoscopy
Procedure: with assistant
head extension by an assistant during direct laryngoscopy
Active Comparator: without assistant
without the help of an assistant during direct laryngoscopy
Procedure: without assistant
without head extension by an assistant during direct laryngoscopy

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing surgery that requires general anesthesia

Exclusion Criteria:

  • disease or injury of cervical spine
  • dentoalveolar injury
  • history of difficult intubation
  • anatomical anomaly of face or airway
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01427348

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01427348     History of Changes
Other Study ID Numbers: JHBahk_dental injury
Study First Received: August 30, 2011
Last Updated: May 28, 2012
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on September 29, 2014