A Randomized Double Blinded Controlled Trial to Investigate the Impact of Needle Manipulation and Accuracy of Between Two Commercially Available Ultrasound Devices
Yale University
Summary
In this double blinded randomized controlled trial, the investigators would like to compare the effects on needle manipulation when relatively inexperienced sonographist (\< 1 year of ultrasound experience) perform ultrasound guided labor epidurals utilizing a traditional handheld ultrasound versus a handheld device that was engineered to provide automated guidance. The primary outcome of this study would be number of needle passes.
Description
Patient will be approached upon admission to labor and delivery floor (Standard of care). The study will be presented to the patient and if they agree, they will be consented. (Study). Upon epidural patient request patient will be randomized to A-US vs B-US based on the randomization table. Ten envelopes will be available with the randomization choice. (Study). The resident will walk in with both US devices into the room (for patient blinding) and perform scan with the device the randomization table called for. (Study). After performing scan and markings of the patients back, the research fell…
Eligibility
- Age range
- 18–45 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * ASA-1, ASA-2, and ASA-3 * Patients with no known back deformities * Ability to sit upright for epidural placement * No prior lumbar surgery * No allergies to ultrasound gel Exclusion Criteria: * Coagulopathy * Low platelet count * Allergies to local anesthetics
Interventions
- DeviceTraditional ultrasound
Labor epidural will be performed after marking patient skin using traditional ultrasound guidance
- DeviceAutomated ultrasound
Labor epidural will be performed after marking patient skin using an automated ultrasound device
Location
- Yale UniversityNew Haven, Connecticut