Accuracy of Depth and Landmark Assessment Using Neuraxial Ultrasound Devices

Pregnancy Clinical Trial

Official title:

Accuracy of Depth and Landmark Assessment Using Neuraxial Ultrasound Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656446
• Other study ID #: 35846
• Status: Completed
• Phase: N/A
• First received: January 8, 2016
• Last updated: April 28, 2017
• Start date: January 2016
• Est. completion date: July 2016

Study information

• Verified date: April 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Device:
• Accuro Handheld Ultrasound
Use of an Accuro Handheld Ultrasound to identify lumbar interspaces, midline, and depth to epidural space
• Standard Ultrasound Machine
Use of standard ultrasound as gold standard to identify lumbar interspaces, midline, and depth to epidural space

Locations

Country	Name	City	State
United States	Lucille Packard Children's Hospital	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Brendan Carvalho

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Midline Identification	The difference between the Accuro Handheld Ultrasound identification of midline and standard ultrasound machine identification of midline	Within 24 Hours of enrollment
Secondary	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
Secondary	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
Secondary	Interspace Levels Attempts	Number of interspace levels attempts for epidural placement	Within 24 Hours of enrollment
Secondary	Epidural Failure Rate	Need for replacement epidural or change in anesthetic technique	Within 24 Hours of enrollment