Pregnancy
Conditions
Keywords
Neuraxial, Ultrasound
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.
Detailed description
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.
Interventions
DEVICEAccuro Handheld Ultrasound
Use of an Accuro Handheld Ultrasound to identify lumbar interspaces, midline, and depth to epidural space
DEVICEStandard Ultrasound Machine
Use of standard ultrasound as gold standard to identify lumbar interspaces, midline, and depth to epidural space
Sponsors
Brendan Carvalho
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depth to Epidural Space | 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
| Measure | Time frame | Description |
|---|---|---|
| Midline Identification | Within 24 Hours of enrollment | The difference between the Accuro Handheld Ultrasound identification of midline and standard ultrasound machine identification of midline |
| Interspace Identification | Within 24 Hours of enrollment | The difference between the Accuro Handheld Ultrasound identification of interspace level and standard ultrasound identification of interspace level |
| Time to Epidural Placement | Within 24 Hours of enrollment | Specifically time from insertion of the Tuohy into the skin until removal of the Tuohy after epidural catheter threading |
| Interspace Levels Attempts | Within 24 Hours of enrollment | Number of interspace levels attempts for epidural placement |
| Epidural Failure Rate | Within 24 Hours of enrollment | Need for replacement epidural or change in anesthetic technique |
Countries
United States
Outcome results
None listed