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Palpation and ACCURO for Placing Spinal in C-section

University of Virginia logo

University of Virginia

Status

Completed

Conditions

Anesthesia,Obstetrical

Treatments

Device: Palpation and Accuro

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • • Patients between the ages of 18 and 45 presenting for a C-section delivery or scheduled for elective Cesarean section

    • ASA-1, ASA-2, and ASA-3
    • Patients with no known back deformities
    • Ability to sit upright for spinal placement
    • No prior lumbar surgery
    • No allergies to ultrasound gel

Exclusion criteria

  • • Unable or unwilling to give informed consent

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

80 participants in 1 patient group

Palpation and Accuro
Experimental group
Description:
The placement site for the spinal anesthesia will be identified using both palpation and Accuro.
Treatment:
Device: Palpation and Accuro

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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