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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accuro Handheld Ultrasound | Device | Use of an Accuro Handheld Ultrasound to identify lumbar interspaces, midline, and depth to epidural space | ||
| Standard Ultrasound Machine | Device | Use of standard ultrasound as gold standard to identify lumbar interspaces, midline, and depth to epidural space |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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50 parturients who decide they want epidural analgesia in labor
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| Name | Affiliation | Role |
|---|---|---|
| Brendan Carvalho, MBBCh, FRCA | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucille Packard Children's Hospital | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22112917 | Background | 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. | |
| 23532866 | Background | 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. |
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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 |
| 19448216 | Background | 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. |
| 19608844 | Background | 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. |
| 28858898 | Derived | 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. |