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
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|
|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|
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
- success rates [ Time Frame: Day 1 ]Success rates: defined as successful spinal administration on the first needle insertion attempt.
- 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.
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
|Contact: Marcia E Birk, RNfirstname.lastname@example.org|
|United States, Virginia|
|University of Virginia Health System||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Marcia E Birk, RN 434-924-2283 email@example.com|
|Principal Investigator:||Mohamed Tiouririne, MD||University of Virginia|