University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Completed
NCT Number: NCT03090295
Palpation and ACCURO for Placing Spinal in C-section
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–45 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Palpation and Accuro
DeviceIdentify placement for spinal
Primary outcomes
-
success rates
Time frame: Day 1
Success rates: defined as successful spinal administration on the first needle insertion attempt.
Secondary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
University of Virginia
Other
Registry information
Official study 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.
Important dates
- Study start
- 2017
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Mar 24, 2017
- Registry last updated
- Mar 10, 2022
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.