Accuracy of Depth and Landmark Assessment Using Neuraxial Ultrasound Devices

Completed

• Conditions: Pregnancy

• Registration Number: NCT02656446
• Lead Sponsor: Brendan Carvalho

Brief 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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-08
• Study First Submitted QC: 2016-01-12
• Study First Posted: 2016-01-15
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• American Society of Anesthesiologists physical status class I, II, or III
• age between 18 and 50
• singleton term pregnancy
• requesting epidural analgesia for anticipated vaginal delivery
• all ethnicities

Exclusion Criteria

• contraindication for epidural analgesia (bleeding diathesis, neuropathy, severe scoliosis, previous spine surgery, local anesthetic allergy)
• inability to adequately understand the consent form

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Depth to Epidural Space	Within 24 Hours of enrollment	Determine the difference between the Accuro ultrasound epidural space depth estimation and actual Tuohy epidural depth during epidural insertion at L3/4

Secondary Outcome Measures

Name	Time	Method
Epidural Failure Rate	Within 24 Hours of enrollment	Need for replacement epidural or change in anesthetic technique
Interspace Identification	Within 24 Hours of enrollment	The difference between the Accuro Handheld Ultrasound identification of interspace level and standard ultrasound identification of interspace level
Time to Epidural Placement	Within 24 Hours of enrollment	Specifically time from insertion of the Tuohy into the skin until removal of the Tuohy after epidural catheter threading
Midline Identification	Within 24 Hours of enrollment	The difference between the Accuro Handheld Ultrasound identification of midline and standard ultrasound machine identification of midline
Interspace Levels Attempts	Within 24 Hours of enrollment	Number of interspace levels attempts for epidural placement

Trial Locations

Locations (1)

Lucille Packard Children's Hospital; 🇺🇸 Palo Alto, California, United States