NCT01908218

Brief Summary

Anticipated difficulties at laryngoscopy give time to prepare alternative method and proper management. Several methods to evaluate the anatomical structures has been used during preoperative period for airway assessment. Evaluation methods are such as the Mallampati classification, mouth opening, thyromental distance and sternocostal distance. the Upper Lip Bite test, evaluates the possibility of a patient cover the mucosa of the upper lip by the lower incisor. The aim of this study was to assess the clinical usefulness of the Upper Lip Bite test(ULBT) in Korean compared to Modified Mallampati classification(MMT).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
344

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2009

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

February 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
Last Updated

July 25, 2013

Status Verified

July 1, 2013

Enrollment Period

Same day

First QC Date

July 17, 2013

Last Update Submit

July 22, 2013

Conditions

Orotracheal Intubation

Keywords

ULBT, diffficult laryngoscopy, Predictive Value of Tests

Outcome Measures

Primary Outcomes (1)

  • Cormack and Lehane grade

    When the patients undergoing general anesthesia with orotracheal intubation, after obtained glottis view with direct laryngoscopy, the performer assessed Cormack and Lehane grade. (It takes about 1 minutes). A grade 1 and 2 were rated as an easy laryngoscopy. Difficult laryngoscopy was defined as the inability to visualize the vocal cords, each includes Grades 3 and 4.

    glottis view with direct laryngoscopy for 1 minute during anesthesia induction

Study Arms (1)

ULBT group

344 adult patients undergoing general anesthesia with orotracheal intubation

Eligibility Criteria

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

adult patients undergoing general anesthesia with orotracheal intubation

You may qualify if:

  • adult patients undergoing general anesthesia with orotracheal intubation

You may not qualify if:

  • patient who have facial anomaly , 2. patients who required a rapid sequence induction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kwandong university colloge of medicine

Seoul, Seoul, South Korea

Location

Related Publications (1)

  • Kim JC, Ki Y, Kim J, Ahn SW. Ethnic considerations in the upper lip bite test: the reliability and validity of the upper lip bite test in predicting difficult laryngoscopy in Koreans. BMC Anesthesiol. 2019 Jan 10;19(1):9. doi: 10.1186/s12871-018-0675-5.

    PMID: 30630419DERIVED

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2013

First Posted

July 25, 2013

Study Start

February 1, 2009

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

July 25, 2013

Record last verified: 2013-07

Locations

KR(1)