Epidural Wave Form Analysis vs Fluoroscopic Guidance for Thoracic Epidural Placement
NCT07217457 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2025-10-16
Summary
The primary objective of this study is to compare the effectiveness of epidural waveform analysis (EWA) with fluoroscopic guidance for confirmation of successful epidural placement. In this study, participants will undergo both EWA and fluoroscopy. EWA involves measuring the pressure in the epidural space once accessed and determining whether or not a waveform that corresponds with the participant's heart rate is present. The pressure measuring apparatus is the same that is used for direct pressure monitoring elsewhere in the body (i.e. invasive arterial catheters or intracranial pressure monitoring).
Conditions
- Epidural Placement
Interventions
- DIAGNOSTIC_TEST
-
Epidural Waveform Analysis
All participants in this study will undergo epidural waveform analysis (pressure measurements) and fluoroscopic guidance of epidural placement. Epidural waveform analysis as method to determine epidural access will be compared to fluoroscopic confirmation.
Sponsors & Collaborators
-
Dartmouth-Hitchcock Medical Center
lead OTHER
Principal Investigators
-
Alexander Abess, MD · Dartmouth-Hitchcock Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-12
- Primary Completion
- 2026-08-31
- Completion
- 2026-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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