Evaluation of Clinical Airway Assessments With a Gray Zone Approach

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jong Hwan Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01719848
First received: October 29, 2012
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

Failure of advanced airway security has been reported that it could lead lethal complication such as brain hypoxic damage. There have been controversial reports for the airway assessment tests which can predict difficult laryngoscopy. Therefore, we evaluated diagnostic validity of pre-existing airway assessment tests and scoring system using a gray zone approach in patients undergoing general anesthesia required endotracheal intubation.


Condition Intervention
Difficult Laryngoscopy
Other: Measurements of parameters related with physical examinations for difficult airway prediction

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Clinical Airway Assessments for Predicting Difficult Laryngoscopy Using a Gray Zone Approach

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Percentage of glottic opening (POGO) [ Time Frame: During laryngoscopy manipulation for endotracheal intubation (average 3min after muscle relaxant is delivered) ] [ Designated as safety issue: Yes ]
    POGO image will be captured using attachable fiberoptic scope.


Estimated Enrollment: 200
Study Start Date: August 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Preoperative airway examination
patients undergoing general anesthesia for any surgery
Other: Measurements of parameters related with physical examinations for difficult airway prediction

Detailed Description:

POGO(percentage of glottic opening)will be evaluated by an attachable fiberoptic scope (AV scope. CAREtec CO.Ltd, Kangwon-Do, South Korea)

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing general anesthesia for any surgery at Samsung medical center

Criteria

Inclusion Criteria:

  • 20 to 80 years old patients undergoing general anesthesia for any operation.

Exclusion Criteria:

  • previous difficult airway history
  • upper airway obstruction disease
  • congenital disorders that are known to relate with difficult airway
  • neurologic symptom associated with neck extension
  • emergent operation
  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: NCT01719848

Locations
Korea, Republic of
Samsung medical center
Seoul, Korea, Republic of, 715-310
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

Responsible Party: Jong Hwan Lee, assistant professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01719848     History of Changes
Other Study ID Numbers: 2012-05-079-001
Study First Received: October 29, 2012
Last Updated: April 16, 2014
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Physical examinations, Percentage of glottic opening(POGO)

ClinicalTrials.gov processed this record on July 31, 2014