Accuracy of Depth and Landmark Assessment Using Neuraxial Ultrasound Devices

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Device: Accuro Handheld Ultrasound; Device: 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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Lucille Packard Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

50 parturients who decide they want epidural analgesia in labor

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brendan Carvalho

Publications and helpful links

General Publications

• Shaikh F, Brzezinski J, Alexander S, Arzola C, Carvalho JC, Beyene J, Sung L. Ultrasound imaging for lumbar punctures and epidural catheterisations: systematic review and meta-analysis. BMJ. 2013 Mar 26;346:f1720. doi: 10.1136/bmj.f1720.
• Carvalho B. Failed epidural top-up for cesarean delivery for failure to progress in labor: the case against single-shot spinal anesthesia. Int J Obstet Anesth. 2012 Oct;21(4):357-9. doi: 10.1016/j.ijoa.2011.06.012. Epub 2011 Nov 22. No abstract available.
• Balki M, Lee Y, Halpern S, Carvalho JC. Ultrasound imaging of the lumbar spine in the transverse plane: the correlation between estimated and actual depth to the epidural space in obese parturients. Anesth Analg. 2009 Jun;108(6):1876-81. doi: 10.1213/ane.0b013e3181a323f6.
• Tran D, Kamani AA, Lessoway VA, Peterson C, Hor KW, Rohling RN. Preinsertion paramedian ultrasound guidance for epidural anesthesia. Anesth Analg. 2009 Aug;109(2):661-7. doi: 10.1213/ane.0b013e3181a94c75.
• Seligman KM, Weiniger CF, Carvalho B. The Accuracy of a Handheld Ultrasound Device for Neuraxial Depth and Landmark Assessment: A Prospective Cohort Trial. Anesth Analg. 2018 Jun;126(6):1995-1998. doi: 10.1213/ANE.0000000000002407.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: January 8, 2016
• First Submitted That Met QC Criteria: January 12, 2016
• First Posted (Estimate): January 15, 2016

Study Record Updates

• Last Update Posted (Actual): May 2, 2017
• Last Update Submitted That Met QC Criteria: April 28, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Ultrasound; Neuraxial
• Other Study ID Numbers: 35846