Comparing a Horizontal Ultrasound Technique With a Palpat... | NCT02271763

Studies
Comparing a Horizontal Ultrasound Technique With a Palpation Technique for Localising the Cricothyroid Membrane

NCT02271763

Sponsor

University of British Columbia

Status

Completed

Last Update Posted

Apr 2, 2015Estimated

Enrollment

37Actual

Phase

Not Applicable

Conditions

Airway Identification

Interventions

ultrasound

Countries

Canada

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

ID	Type	Description	Link
CW14-0188	Other Identifier	Children's & Women's Health Centre of BC

Status Module

Record Verification Date

Mar 2015

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

Sep 2014

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Sep 26, 2014

First Submission Date that Met QC Criteria

Oct 20, 2014

First Posted Date

Oct 22, 2014Estimated

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

Mar 31, 2015

Last Update Posted Date

Apr 2, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 investigators will be comparing a traditional palpation (feeling) technique with an ultrasound technique for finding a specific part of the neck.

Detailed Description

This study compares a traditional palpation (feeling) technique with an ultrasound technique for finding a specific part of the neck. Finding this part of the neck is important for anesthesiologists in emergencies and can sometimes be difficult. We would like to determine if using ultrasound is easier and more reliable than examining the neck by hand. Newer methods using ultrasound have not been studied in detail in the pregnant population.

This study aims to describe a simple technique for identifying the cricothyroid membrane. The secondary aim is to determine how ultrasound compares to palpation in pregnant women at term.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Palpating neck	Active Comparator	Subjects will have their neck palpated by an anesthesiologist to locate their cricothyroid membrane	Other: ultrasound
Ultrasound neck	Experimental	Subjects will have their neck scanned with ultrasound by an anesthesiologist to locate their cricothyroid membrane	Other: ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrasound	Other	subjects' neck will be scanned using ultrasound	Palpating neck Ultrasound neck

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Airway localization	Subjects necks' will be palpated and then scanned using ultrasound	10 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

term pregnancy
19yrs and older

Exclusion Criteria:

preterm pregnancy

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Simon Massey, MD FRCPC	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BC Women's Hospital		Vancouver	British Columbia	V6H 3N1	Canada

Intervention Browse Module

MeSH Terms

ID	Term
D019220	High-Energy Shock Waves

Ancestor Terms

ID	Term
D000069453	Ultrasonic Waves
D013016	Sound
D011840	Radiation, Nonionizing
D011827	Radiation

Browse Leaves

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Browse Branches

Not provided