N/A
N=120
CompuFlo Thoracic Epidural Study
Thoracic Epidural Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT03826186 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Number of Participants With Successful Thoracic Epidural Catheter Placement — 52; 58 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Traditional (loss-of-resistance technique) thoracic epidural placement (Device); CompuFlo thoracic epidural placement (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- YATISH SIDDAPURA RANGANATH
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Thoracic Epidural Catheter Placement |
52; 58 | — |
| SECONDARY Amount of Time Required to Complete the Procedure |
8.02; 7.4 | — |
| SECONDARY Number of Participants Who Reported Loss of Cold Sensation at Various Time Points |
28; 18; 24; 40; 5; 2 | — |
| SECONDARY Mean Arterial Pressure at Baseline and 20 Minutes Post Procedure |
102; 102; 85; 83 | — |
| SECONDARY Number of Participants With Significant Change in Systolic Blood Pressure |
41; 38 | — |
| SECONDARY Number of Participants Whose Provider Answered "Yes" or "No" to Ease of Catheter Placement |
57; 60; 0; 0 | — |
| SECONDARY Number of Participants With a Positive Meniscus Test |
57; 57; 0; 3 | — |
| SECONDARY Number of Participants With Unintentional Dural Puncture |
2; 2 | — |
Summary
Traditionally, loss-of-resistance (LOR) to air or saline with a special ground-glass syringe is the technique used to identify epidural space, but failure rates up to 30% have been reported using this technique for thoracic epidural placement. This failure rate has sparked the search for newer techniques to improve the success rate for placement.The CompuFlo epidural system is a device that provides anesthesiologists and other healthcare providers the ability to quantitatively determine and document the pressure at the needle tip in real time. The device's proprietary dynamic pressure sensing technology (DPS) allows it to provide objective visual and audible in-tissue pressure feedback that allows anesthesiologists to identify the epidural space. The purpose this research study is to compare the success rate of the two different approaches (traditional method v/s CompuFlo assisted) to thoracic epidural placement.
Eligibility Criteria
Inclusion Criteria
- Age: 18 to 70
- BMI: 18 to 50 kg/m2
- Require pain control for major thoracic or abdominal surgeries
- Require pain control for rib fractures
- English is the subject's first language
- Must be able to signed informed consent
Exclusion Criteria
- Age: Less than 18 and older than 70
- Must be free of significant valvular heart disease
- Pregnant women
- Prisoners
- Contraindication to thoracic epidural anesthesia
- Allergy or hypersensitivity to local anesthetics
- Unable to provide written informed consent
Data sourced from ClinicalTrials.gov (NCT03826186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.