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Accuracy of Depth and Landmark Assessment Using Neuraxial Ultrasound Devices

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ClinicalTrials.gov Identifier: NCT02656446
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Brendan Carvalho, Stanford University

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.

Condition or disease Intervention/treatment
Pregnancy 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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Accuracy of Depth and Landmark Assessment Using Neuraxial Ultrasound Devices
Actual Study Start Date : January 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound


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


Primary Outcome Measures :
  1. Depth to Epidural Space [ Time Frame: 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 :
  1. Midline Identification [ Time Frame: Within 24 Hours of enrollment ]
    The difference between the Accuro Handheld Ultrasound identification of midline and standard ultrasound machine identification of midline

  2. Interspace Identification [ Time Frame: Within 24 Hours of enrollment ]
    The difference between the Accuro Handheld Ultrasound identification of interspace level and standard ultrasound identification of interspace level

  3. Time to Epidural Placement [ Time Frame: Within 24 Hours of enrollment ]
    Specifically time from insertion of the Tuohy into the skin until removal of the Tuohy after epidural catheter threading

  4. Interspace Levels Attempts [ Time Frame: Within 24 Hours of enrollment ]
    Number of interspace levels attempts for epidural placement

  5. Epidural Failure Rate [ Time Frame: Within 24 Hours of enrollment ]
    Need for replacement epidural or change in anesthetic technique



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
50 parturients who decide they want epidural analgesia in labor
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656446


Locations
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United States, California
Lucille Packard Children's Hospital
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Brendan Carvalho
Investigators
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Principal Investigator: Brendan Carvalho, MBBCh, FRCA Stanford University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brendan Carvalho, Chief of Obstetric Anesthesia, Professor - Department of Anesthesiology, Stanford University
ClinicalTrials.gov Identifier: NCT02656446     History of Changes
Other Study ID Numbers: 35846
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: April 2017

Keywords provided by Brendan Carvalho, Stanford University:
Neuraxial
Ultrasound