NCT03060187

Brief Summary

The purpose of this observational study is to evaluate the usefulness of Kansas University airway exam score ("KU score") in predicting difficulty of placement of a breathing tube into the windpipe.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

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

February 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

11 months

First QC Date

January 27, 2017

Last Update Submit

February 17, 2017

Conditions

Intubation

Outcome Measures

Primary Outcomes (1)

  • Correlation between KU score and intubation difficulty scale (IDS) measure

    The measure is assessed during the time period between the start of preoperative examination on the day of surgery and completion of a standard tracheal intubation in the operating room. Correlation measured using the Spearman correlation coefficient.

    Time between preoperative exam to after intubation, up to 3 hours

Study Arms (1)

KU Score

Participants asked to answer questions for the KU Score exam

Other: KU Score

Interventions

KU ScoreOTHER

Exam with a max score of 10 and min score of 0. Designed as a preoperative assessment of the patient's airway.

KU Score

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will include persons presenting to the University of Kansas Hospital to have surgery under standard general anesthesia.

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status I-IV
  • Patients scheduled for a surgical or any other diagnostic or therapeutic procedure that requires endotracheal intubation (ETI)

You may not qualify if:

  • Patients scheduled for an emergent surgery
  • Obstetric patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Study Officials

  • Mirsad Dupanović, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2017

First Posted

February 23, 2017

Study Start

February 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

US(1)