Evaluation of Clinical Airway Assessments With a Gray Zone Approach

Difficult Laryngoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01719848
• Other study ID #: 2012-05-079-001
• Status: Completed
• Phase: N/A
• First received: October 29, 2012
• Last updated: April 16, 2014
• Start date: August 2012
• Est. completion date: July 2013

Study information

• Verified date: April 2014
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Difficult Laryngoscopy

Intervention

Other:
• Measurements of parameters related with physical examinations for difficult airway prediction

Locations

Country	Name	City	State
Korea, Republic of	Samsung medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of glottic opening (POGO)	POGO image will be captured using attachable fiberoptic scope.	During laryngoscopy manipulation for endotracheal intubation (average 3min after muscle relaxant is delivered)	Yes