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

NCT03182608 | Completed

• 1 other identifier: 16-2017-46
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (1)

• The estimation ratio related to the intervertebral levels

  Baseline

Study Arms (2)

Group 1

EXPERIMENTAL

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.

Diagnostic Test: Noninvasive ultrasound assessment

Group 2

EXPERIMENTAL

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.

Diagnostic Test: Noninvasive ultrasound assessment

Interventions

Noninvasive ultrasound assessment DIAGNOSTIC_TEST

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.

Group 1; Group 2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients scheduled for hip fracture surgery under spinal anesthesia

You may not qualify if:

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

Sponsors & Collaborators

• SMG-SNU Boramae Medical Center: lead

Study Sites (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 156-707, South Korea

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Jin-Young Hwang

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: Crossover

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: June 9, 2017
• Study Start: June 9, 2017
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: April 3, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)