Epidural Wave Form Analysis vs Fluoroscopic Guidance for Thoracic Epidural Placement

NCT07217457 | Enrolling By Invitation FDA Device

• 1 other identifier: STUDY02002726
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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).

Conditions

Epidural Placement

Keywords

epidural waveform; fluoroscopic guidance; thoracic epidural

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Study Cohort

EXPERIMENTAL

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

Interventions

Epidural Waveform Analysis DIAGNOSTIC_TEST

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.

Study Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (2)

• Hong JH, Jung SW. Analysis of epidural waveform for cervical epidural steroid injections confirmed with fluoroscopy. Medicine (Baltimore). 2018 Mar;97(13):e0202. doi: 10.1097/MD.0000000000010202.

  PMID: 29595657 BACKGROUND

• Arnuntasupakul V, Van Zundert TC, Vijitpavan A, Aliste J, Engsusophon P, Leurcharusmee P, Ah-Kye S, Finlayson RJ, Tran DQ. A Randomized Comparison Between Conventional and Waveform-Confirmed Loss of Resistance for Thoracic Epidural Blocks. Reg Anesth Pain Med. 2016 May-Jun;41(3):368-73. doi: 10.1097/AAP.0000000000000369.

  PMID: 26894628 BACKGROUND

Study Officials

• Alexander Abess, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 12, 2025
• First Posted: October 16, 2025
• Study Start: September 12, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)