Proposal and Clinical Evaluation of a Comprehensive Airwa... | NCT03060187

Studies
Proposal and Clinical Evaluation of a Comprehensive Airway Exam Score

NCT03060187

Sponsor

University of Kansas Medical Center

Status

Completed

Last Update Posted

Feb 23, 2017Actual

Enrollment

2,000Actual

Phase

Not provided

Conditions

Intubation

Interventions

KU Score

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010Actual

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Jan 27, 2017

First Submission Date that Met QC Criteria

Feb 17, 2017

First Posted Date

Feb 23, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2017

Last Update Posted Date

Feb 23, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
KU Score		Participants asked to answer questions for the KU Score exam	Other: KU Score

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KU Score	Other	Exam with a max score of 10 and min score of 0. Designed as a preoperative assessment of the patient's airway.	KU Score

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mirsad Dupanović, MD	University of Kansas Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kansas Medical Center		Kansas City	Kansas	66160	United States