- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03182608
Ultrasound Assessment of the Anatomic Landmarks for Spinal Anesthesia in Patients With Hip Fracture
April 2, 2018 updated by: Jin-Young Hwang, SMG-SNU Boramae Medical Center
Investigators assess the anatomic landmarks for spinal anesthesia in patients with hip fracture using ultrasonography.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 156-707
- Seoul Metropolitan Government Seoul National University Boramae Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1
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.
|
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.
|
|
Experimental: Group 2
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of each anatomic landmark (Tuffier's line and tenth rib line).
Time Frame: Baseline
|
Actual interspinous levels of the landmark-guided approches (Tuffier's line and tenth rib line) are assessed using ultrasonography.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The estimation ratio related to the intervertebral levels
Time Frame: Baseline
|
Actual interspinous levels of the landmark-guided approches (Tuffier's line and tenth rib line) are assessed using ultrasonography.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jin-Young Hwang, SMG-SNU Boramae Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 9, 2017
Primary Completion (Actual)
March 31, 2018
Study Completion (Actual)
March 31, 2018
Study Registration Dates
First Submitted
May 26, 2017
First Submitted That Met QC Criteria
June 7, 2017
First Posted (Actual)
June 9, 2017
Study Record Updates
Last Update Posted (Actual)
April 3, 2018
Last Update Submitted That Met QC Criteria
April 2, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-2017-46
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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