Clinical trial NCT02656446: Accuracy of Depth and Landmark Assessment Using Neuraxial Ultrasound Devices
Official title: Accuracy of Depth and Landmark Assessment Using Neuraxial Ultrasound Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: Neuraxial
Ultrasound
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-01-15
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 parturients who decide they want epidural analgesia in labor

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.

Eligibility criteria: 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

Primary outcomes:
measure: Depth to Epidural Space
timeFrame: Within 24 Hours of enrollment
Secondary outcomes:
measure: Midline Identification
timeFrame: Within 24 Hours of enrollment
measure: Interspace Identification
timeFrame: Within 24 Hours of enrollment
measure: Time to Epidural Placement
timeFrame: Within 24 Hours of enrollment
measure: Interspace Levels Attempts
timeFrame: Within 24 Hours of enrollment
measure: Epidural Failure Rate
timeFrame: Within 24 Hours of enrollment
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucille Packard Children's Hospital
state: California
Study officials:
affiliation: Stanford University
name: Brendan Carvalho, MBBCh, FRCA
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available.
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.
citation: 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.
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.
citation: 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.