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Palpation and ACCURO for Placing Spinal in C-section

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ClinicalTrials.gov Identifier: NCT03090295
Recruitment Status : Unknown
Verified March 2017 by Mohamed Tiouririne, MD, University of Virginia.
Recruitment status was:  Recruiting
First Posted : March 24, 2017
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamed Tiouririne, MD, University of Virginia

Brief Summary:

The Accuro is a three dimensional handheld ultrasound device. This device uses sound waves to create pictures of the spine in three dimensions. This may allow the physician to view the spine in more detail for procedures such as spinal anesthesia and other diagnostic procedures.

We aim to assess the benefit of using both the Accuro and traditional landmark palpation technique to determine accurate spinal level in women who undergo cesarean section. This study will also assess provider preference for use of both Accuro and palpation compared with palpation alone or use of Accuro alone.

Anesthesia Providers will first identify the L4/L5 space using the traditional technique of palpating the iliac crests to estimate spinal level, which will be marked with a single dot from a marking pen. The provider will then use the Accuro 3000 to identify the L4/L5 interspace.

Results will be compared to results obtained in IRB 18070 "Handheld 3D lumbar spine navigation: A clinical validation study RM002" where subjects who were undergoing a C-section were randomized to either palpation or Accuro alone.


Condition or disease Intervention/treatment Phase
Anesthesia,Obstetrical Device: Palpation and Accuro Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Does the Use of Both Palpation and Accuro as Compared to Palpation Alone or Use of Accuro Alone in a Single Patient Increase the First Pass Success Rate in Placing Spinals or Combined Spinal Epidurals for Cesarean Sections.
Actual Study Start Date : March 13, 2017
Estimated Primary Completion Date : March 30, 2018
Estimated Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: Palpation and Accuro
The placement site for the spinal anesthesia will be identified using both palpation and Accuro.
Device: Palpation and Accuro
Identify placement for spinal




Primary Outcome Measures :
  1. success rates [ Time Frame: Day 1 ]
    Success rates: defined as successful spinal administration on the first needle insertion attempt.


Secondary Outcome Measures :
  1. Level of spinal placement: a record of the vertebral level where the spinal is administered. [ Time Frame: Day 1 ]
    Level of spinal placement: a record of the vertebral level where the spinal is administered.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Patients between the ages of 18 and 45 presenting for a C-section delivery or scheduled for elective Cesarean section

    • ASA-1, ASA-2, and ASA-3
    • Patients with no known back deformities
    • Ability to sit upright for spinal placement
    • No prior lumbar surgery
    • No allergies to ultrasound gel

Exclusion Criteria:

  • • Unable or unwilling to give informed consent

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): NCT03090295


Contacts
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Contact: Marcia E Birk, RN 434-924-2283 meb2w@virginia.edu

Locations
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United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Marcia E Birk, RN    434-924-2283    meb2w@virginia.edu   
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Mohamed Tiouririne, MD University of Virginia

Publications:
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Responsible Party: Mohamed Tiouririne, MD, Associate Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT03090295     History of Changes
Other Study ID Numbers: 19713
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No