NCT02656446

Accuracy of Depth and Landmark Assessment Using Neuraxial Ultrasound Devices

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Brendan Carvalho · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if a handheld ultrasound device helps in the placement of labor epidurals by studying the accuracy of the Accuro Handheld Ultrasound device compared to a standard ultrasound machine.

Detailed description

Pregnant women who present to Labor and Delivery for an anticipated vaginal delivery will be identified as potential participants based on inclusion/exclusion criteria and their desire for labor epidural analgesia. Ultrasound evaluations will be conducted in a cohort of 50 parturients who decide they want epidural analgesia in labor. Prior to epidural placement, a hand held ultrasound device will be utilized to identify L2/3, L3/4 and L4/5 interspace. A mark will be made on the patient's back at these levels. The handheld ultrasound device will also estimate the depth to epidural space at each level using its programmed algorithm. A standard ultrasound will then be used to locate the same interspaces, identify midline, and estimate depth to epidural space with caliper calculation. Upon patient request, an epidural will be placed at L3/4 with a loss of resistance to saline technique. The actual depth to loss of resistance during epidural insertion will be determined by measuring the Tuohy with a sterile measuring tape while it is in the skin.

Conditions

• Pregnancy

Interventions

Type	Name	Description
DEVICE	Accuro Handheld Ultrasound	Use of an Accuro Handheld Ultrasound to identify lumbar interspaces, midline, and depth to epidural space
DEVICE	Standard Ultrasound Machine	Use of standard ultrasound as gold standard to identify lumbar interspaces, midline, and depth to epidural space

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2016-01-15
• Last updated: 2017-05-02

Locations

1 site across 1 country: United States