Evaluation of Clinical Airway Assessments With a Gray Zone Approach

April 16, 2014 updated by: Jong Hwan Lee, Samsung Medical Center

Evaluation of Clinical Airway Assessments for Predicting Difficult Laryngoscopy Using a Gray Zone Approach

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing general anesthesia for any surgery at Samsung medical center

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Preoperative airway examination
patients undergoing general anesthesia for any surgery
Other: Measurements of parameters related with physical examinations for difficult airway prediction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of glottic opening (POGO)
Time Frame: During laryngoscopy manipulation for endotracheal intubation (average 3min after muscle relaxant is delivered)
POGO image will be captured using attachable fiberoptic scope.
During laryngoscopy manipulation for endotracheal intubation (average 3min after muscle relaxant is delivered)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

October 29, 2012

First Submitted That Met QC Criteria

October 30, 2012

First Posted (Estimate)

November 1, 2012

Study Record Updates

Last Update Posted (Estimate)

April 17, 2014

Last Update Submitted That Met QC Criteria

April 16, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012-05-079-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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