NCT03090295

Palpation and ACCURO for Placing Spinal in C-section

Does the Use of Both Palpation and Accuro as Compared to Palpation Alone or Use of Accuro Alone in a Single Patient Increase the First Pass Success Rate in Placing Spinals or Combined Spinal Epidurals for Cesarean Sections.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Palpation and Accuro	Identify placement for spinal

Timeline

• Start date: 2017-03-13
• Primary completion: 2018-03-30
• Completion: 2018-03-30
• First posted: 2017-03-24
• Last updated: 2022-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study