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Palpation and ACCURO for Placing Spinal in C-section

NCT03090295 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-03-10

No results posted yet for this study

Summary

The Accuro is a three dimensional handheld ultrasound device. This device uses sound waves to create pictures of the spine in three dimensions. This may allow the physician to view the spine in more detail for procedures such as spinal anesthesia and other diagnostic procedures.

We aim to assess the benefit of using both the Accuro and traditional landmark palpation technique to determine accurate spinal level in women who undergo cesarean section. This study will also assess provider preference for use of both Accuro and palpation compared with palpation alone or use of Accuro alone.

Anesthesia Providers will first identify the L4/L5 space using the traditional technique of palpating the iliac crests to estimate spinal level, which will be marked with a single dot from a marking pen. The provider will then use the Accuro 3000 to identify the L4/L5 interspace.

Results will be compared to results obtained in IRB 18070 "Handheld 3D lumbar spine navigation: A clinical validation study RM002" where subjects who were undergoing a C-section were randomized to either palpation or Accuro alone.

Conditions

  • Anesthesia,Obstetrical

Interventions

DEVICE

Palpation and Accuro

Identify placement for spinal

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Mohamed Tiouririne, MD · University of Virginia

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-13
Primary Completion
2018-03-30
Completion
2018-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03090295 on ClinicalTrials.gov