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Ultrasound Assessment of the Anatomic Landmarks for Spinal Anesthesia in Patients With Hip Fracture

Primary Purpose

Hip Fractures

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Noninvasive ultrasound assessment

About this trial

This is an interventional diagnostic trial for Hip Fractures

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients scheduled for hip fracture surgery under spinal anesthesia

Exclusion Criteria:

Anatomic abnormalities or masses in the spine
History of spinal surgery of compression fracture

Sites / Locations

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group 1

Group 2

Arm Description

In the lateral decubitus position, an investigator evaluate the L4-5 interspinous level using an anatomic landmark (Tuffier's line), and then evaluate the L4-5 interspinous level using another anatomic landmark (Tenth rib line). Another investigator evaluate the actual L4-5 interspinous level by noninvasive ultrasonography.

In the lateral decubitus position, an investigator evaluate the L4-5 interspinous level using an anatomic landmark (Tenth rib line), and then evaluate the L4-5 interspinous level using another anatomic landmark (Tuffier's line). Another investigator evaluate the actual L4-5 interspinous level by noninvasive ultrasonography.

Outcomes

Primary Outcome Measures

Accuracy of each anatomic landmark (Tuffier's line and tenth rib line).

Actual interspinous levels of the landmark-guided approches (Tuffier's line and tenth rib line) are assessed using ultrasonography.

Secondary Outcome Measures

The estimation ratio related to the intervertebral levels

Actual interspinous levels of the landmark-guided approches (Tuffier's line and tenth rib line) are assessed using ultrasonography.

Full Information

NCT ID

NCT03182608

First Posted

May 26, 2017

Last Updated

April 2, 2018

Sponsor

SMG-SNU Boramae Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03182608

Brief Title

Ultrasound Assessment of the Anatomic Landmarks for Spinal Anesthesia in Patients With Hip Fracture

Official Title

Ultrasound Assessment of the Anatomic Landmarks for Spinal Anesthesia in Patients With Hip Fracture

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

June 9, 2017 (Actual)

Primary Completion Date

March 31, 2018 (Actual)

Study Completion Date

March 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

SMG-SNU Boramae Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Investigators assess the anatomic landmarks for spinal anesthesia in patients with hip fracture using ultrasonography.

Detailed Description

Investigators evaluate the anatomic landmarks using Tuffier's line and the tenth rib line for spinal anesthesia in patients with hip fracture, and then assess the consistency of the landmarks-guided interspinous levels with the actual interspinous level using ultrasonography.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Fractures

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Crossover

Masking

ParticipantOutcomes Assessor

Masking Description

An investigator evaluate the interspinous level using anatomic landmarks, then other independent investigator assess the consistency of the landmarks-guided interspinous level with the actual one using ultrasonography. Participants are blinded to the assessment results.

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

Noninvasive ultrasound assessment

Intervention Description

An investigator evaluate the L4-5 interspinous level using anatomic landmarks in turn, then another independent investigator assess the consistency of the landmarks-guided interspinous level with the actual one by noninvasive ultrasound assessment.

Primary Outcome Measure Information:

Title

Accuracy of each anatomic landmark (Tuffier's line and tenth rib line).

Description

Actual interspinous levels of the landmark-guided approches (Tuffier's line and tenth rib line) are assessed using ultrasonography.

Time Frame

Baseline

Secondary Outcome Measure Information:

Title

The estimation ratio related to the intervertebral levels

Description

Actual interspinous levels of the landmark-guided approches (Tuffier's line and tenth rib line) are assessed using ultrasonography.

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients scheduled for hip fracture surgery under spinal anesthesia Exclusion Criteria: Anatomic abnormalities or masses in the spine History of spinal surgery of compression fracture

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jin-Young Hwang

Organizational Affiliation

SMG-SNU Boramae Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul Metropolitan Government Seoul National University Boramae Medical Center

City

Seoul

ZIP/Postal Code

156-707

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Ultrasound Assessment of the Anatomic Landmarks for Spinal Anesthesia in Patients With Hip Fracture

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