Epidural PlacementNCT07217457
Epidural Wave Form Analysis vs Fluoroscopic Guidance for Thoracic Epidural Placement
A study testing Epidural Waveform Analysis in people with Epidural Placement, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epidural Placement
- What is being tested?
- Epidural Waveform Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non-english speaking
- Incarceration
- Pregnant
- Minors (under age 18)
- Inability to provide consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
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).
Read the 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.
- Conditions
- Epidural Placement
- Being tested
- Epidural Waveform Analysis
- Keywords
- epidural waveform, fluoroscopic guidance, thoracic epidural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural Waveform AnalysisDiagnostic 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Epidural Waveform Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Predictive Value and Negative Predictive Value of epidural waveform analysis to predict epidural access compared with fluoroscopic guidance
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2025
- Study start12 Sep 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Epidural PlacementStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander T. Abess, Dartmouth-Hitchcock Medical Center
- Investigators
- Alexander Abess, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217457
- Sponsor's protocol ID
- STUDY02002726
- Status last verified
- Oct 2025
- First submitted
- 12 Oct 2025
- Last updated
- 16 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Publications
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.
PubMed 29595657Arnuntasupakul 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.
PubMed 26894628
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Wave Form Analysis vs Fluoroscopic Guidance for Thoracic Epidural Placement
- ClinicalTrials.gov ID
- NCT07217457
- Acronym / sponsor ID
- STUDY02002726
- Conditions
- Epidural Placement
- Keywords
- epidural waveform, fluoroscopic guidance, thoracic epidural
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | Experimental | Diagnostic Test: Epidural Waveform AnalysisThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Non-english speaking
- Incarceration
- Pregnant
- Minors (under age 18)
- Inability to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural Waveform AnalysisAll 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. | Diagnostic test | Study Cohort |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Background: PubMed 29595657Hong 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.
- Background: PubMed 26894628Arnuntasupakul 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Abess, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural Waveform Analysis in people with Epidural Placement, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07217457, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.