Palpation and ACCURO for Placing Spinal in C-section

Not Applicable

Completed

• Conditions: Anesthesia,Obstetrical
• Interventions: Device: Palpation and Accuro

• Registration Number: NCT03090295
• Lead Sponsor: University of Virginia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-13
• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-20
• Study First Posted: 2017-03-24
• Primary Completion: 2018-03-30
• Study Completion: 2018-03-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Palpation and Accuro	Palpation and Accuro	The placement site for the spinal anesthesia will be identified using both palpation and Accuro.

Primary Outcome Measures

Name	Time	Method
success rates	Day 1	Success rates: defined as successful spinal administration on the first needle insertion attempt.

Secondary Outcome Measures

Name	Time	Method
Level of spinal placement: a record of the vertebral level where the spinal is administered.	Day 1	Level of spinal placement: a record of the vertebral level where the spinal is administered.

Trial Locations

Locations (1)

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States