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CompuFlo Thoracic Epidural Study

NCT03826186 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-10-19

Study results available
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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.

Conditions

  • Thoracic Epidural Anesthesia

Interventions

DEVICE

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

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

DEVICE

CompuFlo thoracic epidural placement

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

Sponsors & Collaborators

  • YATISH SIDDAPURA RANGANATH

    lead OTHER

Principal Investigators

  • Yatish S Ranganath, MD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-26
Primary Completion
2022-01-01
Completion
2022-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03826186 on ClinicalTrials.gov