What this study is
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.
What's being tested
- Traditional ultrasound
Intervention · DEVICE
Labor epidural will be performed after marking patient skin using traditional ultrasound guidance
- Automated ultrasound
Intervention · DEVICE
Labor epidural will be performed after marking patient skin using an automated ultrasound device
Study details
- Official title
- A Randomized Double Blinded Controlled Trial to Investigate the Impact of Needle Manipulation and Accuracy of Between Two Commercially Available Ultrasound Devices
- Sponsor
- Yale University
- Conditions
- Labor Analgesia
- Enrolling
- 200 people
- Starts
- 2027-07-01
- Est. completion
- 2027-12
- Design
- Double-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 45 YearsSex FEMALEHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- Coagulopathy
- Low platelet count
- Allergies to local anesthetics
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openYale University
New Haven, Connecticut, United States
Study team
Sponsor
Yale University
Study ID 2000034863
Principal investigator
Antonio Gonzalez, MD
Yale University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.