- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03060187
Proposal and Clinical Evaluation of a Comprehensive Airway Exam Score
February 17, 2017 updated by: University of Kansas Medical Center
The "KU Score": Proposal and Clinical Evaluation of a Comprehensive Airway Exam Score; an Observational Study
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
2000
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
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants will include persons presenting to the University of Kansas Hospital to have surgery under standard general anesthesia.
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Patients scheduled for an emergent surgery
- Obstetric patients
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 |
|---|---|
|
KU Score
Participants asked to answer questions for the KU Score exam
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Exam with a max score of 10 and min score of 0. Designed as a preoperative assessment of the patient's airway.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between KU score and intubation difficulty scale (IDS) measure
Time Frame: Time between preoperative exam to after intubation, up to 3 hours
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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.
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Time between preoperative exam to after intubation, up to 3 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mirsad Dupanović, MD, University of Kansas Medical Center
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 (Actual)
February 1, 2010
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
January 27, 2017
First Submitted That Met QC Criteria
February 17, 2017
First Posted (Actual)
February 23, 2017
Study Record Updates
Last Update Posted (Actual)
February 23, 2017
Last Update Submitted That Met QC Criteria
February 17, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 12093
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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