CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
Traditional (loss-of-resistance technique) thoracic epidural placement +1 moredevice
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03826186
NCT03826186N/ACompleted

Traditional Loss-of-resistance Technique vs Compuflo-aided Technology for Placement of a Thoracic Epidural Catheter: a Randomized Trial of the Effect on the Success Rate

YATISH SIDDAPURA RANGANATH·interventional·Posted Feb 1, 2019·Updated Oct 19, 2022

In Brief

A clinical study evaluating Traditional (loss-of-resistance technique) thoracic epidural placement and CompuFlo thoracic epidural placement for Thoracic Epidural Anesthesia. Completed, enrolled 120 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 1, 2019
Enrollment StartMar 26, 2019
Primary CompletionJan 1, 2022
Study CompletionJun 1, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 7.4 years ago

Interventions

Traditional (loss-of-resistance technique) thoracic epidural placementdevice

Thoracic epidurals will be administered using the traditional loss-of resistance technique.

CompuFlo thoracic epidural placementdevice

Pressure sensing technology to consistently and accurately identify the thoracic epidural space.