The Use of Ultrasound to Measure Depth of Thoracic Epidur... | NCT01172730

Studies
The Use of Ultrasound to Measure Depth of Thoracic Epidural Space

NCT01172730

Sponsor

University of Massachusetts, Worcester

Status

Completed

Last Update Posted

Apr 11, 2013Estimated

Enrollment

29Actual

Phase

Not provided

Conditions

Post Operative Trauma
Acute Pain

Interventions

Ultrasound scanning

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

Apr 2013

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

May 2010

Primary Completion Date

Apr 2013Actual

Completion Date

Not provided

First Submitted Date

May 24, 2010

First Submission Date that Met QC Criteria

Jul 29, 2010

First Posted Date

Jul 30, 2010Estimated

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

Apr 9, 2013

Last Update Posted Date

Apr 11, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Issam Khayata, Study Principle Investigator, University of Massachusetts, WorcesterPrincipal Investigator

Lead Sponsor

University of Massachusetts, WorcesterOTHER

Collaborators

Not provided

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 purpose of the study is to evaluate the use of ultrasound scanning of the thoracic spine to define the point of insertion and the depth of the epidural space compared to the blind technique.

The study hypothesis is the use of Ultrasound will improve the success rate of epidural placement and may also decrease the rate of complications.

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

Not provided

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

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ultrasound scanning			Device: Ultrasound scanning

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound scanning	Device	Ultrasound scanning is used to define needle insertion point and depth of epidural space.	Ultrasound scanning

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The success rate of epidural catheter to control pain		post operative day # 1

Secondary Outcomes

Measure	Description	Time Frame
The complication rate from epidural catheter placement.		Immediate complications 24 hrs after

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients 18 years and older having a thoracic epidural catheter
Both male and female patients.

Exclusion Criteria:

Pediatric population < 18 years of age
Pregnancy
Prisoners
Absolute Contraindication to thoracic epidural placement severe scoliosis or deformity,
Patients with previous spine surgery or hardware implanted at level of epidural placement,
Anticipated ventilation postoperatively for a period more that 24 hrs
Lack of patient consent to enroll in the study

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

Patients having a thoracic epidural catheter for post operative pain

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Issam Khayata, MD	University of Massachusetts, Worcester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UMass Memorial Medical Center		Worcester	Massachusetts	01655	United States

Condition Browse Module

MeSH Terms

ID	Term
D059787	Acute Pain
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

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