NCT01719848

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

April 17, 2014

Status Verified

April 1, 2014

Enrollment Period

11 months

First QC Date

October 29, 2012

Last Update Submit

April 16, 2014

Conditions

Difficult Laryngoscopy

Keywords

Physical examinations, Percentage of glottic opening(POGO)

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

Preoperative airway examination

patients undergoing general anesthesia for any surgery

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

Interventions

Measurements of parameters related with physical examinations for difficult airway predictionOTHER
Preoperative airway examination

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing general anesthesia for any surgery at Samsung medical center

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung medical center

Seoul, 715-310, South Korea

Location

Related Publications (1)

  • Min JJ, Kim G, Kim E, Lee JH. The diagnostic validity of clinical airway assessments for predicting difficult laryngoscopy using a grey zone approach. J Int Med Res. 2016 Aug;44(4):893-904. doi: 10.1177/0300060516642647. Epub 2016 Jun 6.

    PMID: 27268499DERIVED

MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

October 29, 2012

First Posted

November 1, 2012

Study Start

August 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

April 17, 2014

Record last verified: 2014-04

Locations

KR(1)