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Completed

NCT Number: NCT02656446

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.

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Key information

Conditions

Pregnancy

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Lucille Packard Children's Hospital

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Brendan Carvalho

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 15, 2016
Registry last updated
May 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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