Epidural Wave Form Analysis vs Fluoroscopic Guidance for Thoracic Epidural Placement

Not Applicable

• Conditions: Epidural Placement

• Registration Number: NCT07217457
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief 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).

Detailed Description

The primary objective of this study is to assess the accuracy with which epidural waveform analysis (EWA) can confirm epidural access in comparison to the gold standard of fluoroscopic confirmation (FC). Our hypothesis is that FC is superior to EWA. We will determine the Positive Predictive Value and Negative Predictive Value of EWA referenced to FC.

If EWA performs reasonably well compared to FC, then EWA could be used in settings where anesthesia providers do not have access to fluoroscopy or the expertise to perform fluoroscopic-guided thoracic epidurals. EWA uses clinically approved pressure transducers, which are used commonly to analyze other physiologic pressures (e.g. invasive hemodynamic monitoring and invasive intracranial pressure monitoring.) and could offer a low budget way to help reassure that placement of a needle is indeed epidural, and not in a different location.

Study Timeline

• Study Start: 2025-09-12
• Status Verified: 2025-10
• Study First Submitted: 2025-10-12
• Study First Submitted QC: 2025-10-14
• Last Update Submitted: 2025-10-14
• Study First Posted: 2025-10-16
• Last Update Posted: 2025-10-16
• Primary Completion: 2026-08-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• 18 years or older
• Undergoing surgery at Dartmouth Hitchcock Medical Center
• Scheduled for planned (non-emergent, non-urgent) thoracic epidural placement as part of surgery and anesthesia
• English speaking
• Must have capacity for consent

Exclusion Criteria

• Non-english speaking
• Incarceration
• Pregnant
• Minors (under age 18)
• Inability to provide consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Positive Predictive Value and Negative Predictive Value of epidural waveform analysis to predict epidural access compared with fluoroscopic guidance	Time of enrollment through completion of epidural placement. Epidural placement occurs on study day 1 and is generally completed within 2 hours of study enrollment.

Trial Locations

Locations (1)

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States