Ultrasound Guidance for Epidural Analgesia and Anesthesia | NCT02436109

Studies
Ultrasound Guidance for Epidural Analgesia and Anesthesia

NCT02436109

Sponsor

University of British Columbia

Status

Terminated

Last Update Posted

Nov 17, 2016Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Epidural Space Depth

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

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

study device broke

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Mar 31, 2015

First Submission Date that Met QC Criteria

May 1, 2015

First Posted Date

May 6, 2015Estimated

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

Nov 15, 2016

Last Update Posted Date

Nov 17, 2016Estimated

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

Most women delivering by cesarean at BC Women's receive regional anesthesia; which includes spinal, epidural, or combined spinal-epidural anesthesia. In all these techniques a needle is placed in the lower back and local anesthetic is injected to freeze the body. Normally, before the needle is placed in a patients' back, the anesthesiologist will feel between their back bones with his/her fingers to find the right spot for the needle. This study will be evaluating if the distance from the skin to the appropriate spinal space measured with a novel 3D Ultrasound will equal the actual depth of the needle insertion.

Detailed Description

The investigators will be evaluating if the distance from the skin to the appropriate spinal space measured with a novel 3D Ultrasound will equal the actual depth of the needle insertion.

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

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group		elective cesarean delivery patients	Device: Ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound	Device	Parturients backs will be scanned using 3D ultrasound to measure the depth to the epidural space	study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
epidural space depth	comparison of ultrasound measured epidural space to actual needle insertion	intraoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

term pregnancy
elective cesarean

Exclusion Criteria:

scoliosis
high bmi

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

pregnant women

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vit Gunka, 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
D014463	Ultrasonography

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided