NCT02656446

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

May 2, 2017

Status Verified

April 1, 2017

Enrollment Period

6 months

First QC Date

January 8, 2016

Last Update Submit

April 28, 2017

Conditions

Pregnancy

Keywords

NeuraxialUltrasound

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Midline Identification

    Within 24 Hours of enrollment

  • Interspace Identification

    Within 24 Hours of enrollment

  • Time to Epidural Placement

    Within 24 Hours of enrollment

  • Interspace Levels Attempts

    Within 24 Hours of enrollment

  • Epidural Failure Rate

    Within 24 Hours of enrollment

Interventions

Accuro Handheld UltrasoundDEVICE

Use of an Accuro Handheld Ultrasound to identify lumbar interspaces, midline, and depth to epidural space

Standard Ultrasound MachineDEVICE

Use of standard ultrasound as gold standard to identify lumbar interspaces, midline, and depth to epidural space

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

50 parturients who decide they want epidural analgesia in labor

You may qualify if:

  • 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

You may not qualify if:

  • contraindication for epidural analgesia (bleeding diathesis, neuropathy, severe scoliosis, previous spine surgery, local anesthetic allergy)
  • inability to adequately understand the consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucille Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

Related Publications (5)

  • 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.

    PMID: 22112917BACKGROUND

  • 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.

    PMID: 23532866BACKGROUND

  • 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.

    PMID: 19448216BACKGROUND

  • 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.

    PMID: 19608844BACKGROUND

  • 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.

    PMID: 28858898DERIVED

Study Officials

  • Brendan Carvalho, MBBCh, FRCA

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief of Obstetric Anesthesia, Professor - Department of Anesthesiology

Study Record Dates

First Submitted

January 8, 2016

First Posted

January 15, 2016

Study Start

January 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

May 2, 2017

Record last verified: 2017-04

Locations

US(1)