Epidural Wave Form Analysis vs Fluoroscopic Guidance for Thoracic Epidural Placement

October 14, 2025 updated by: Alexander T. Abess, Dartmouth-Hitchcock Medical Center
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).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Cohort
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.Every participant enrolled in the study will be in the experimental arm and will undergo epidural waveform analysis and fluoroscopic confirmation of epidural access.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Positive Predictive Value and Negative Predictive Value of epidural waveform analysis to predict epidural access compared with fluoroscopic guidance
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Investigators

  • Principal Investigator: Alexander Abess, MD, Dartmouth-Hitchcock Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 12, 2025

First Submitted That Met QC Criteria

October 14, 2025

First Posted (Estimated)

October 16, 2025

Study Record Updates

Last Update Posted (Estimated)

October 16, 2025

Last Update Submitted That Met QC Criteria

October 14, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY02002726

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participant privacy considerations remain paramount. De-identified data could be shared at some point if deemed helpful by other researchers and if approved by our institution review board and privacy officers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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