Compuflo Instrument for Thoracic ES Identification

November 10, 2020 updated by: Ralf E. Gebhard, MD, University of Miami

Evaluation of the Compuflo Epidural Instrument for Thoracic Epidural Space Identification

The purpose of this pilot study is to evaluate whether the Compuflo Epidural Instrument injection pump technology, which is FDA approved for lumbar epidural anesthesia, is also capable of identifying the thoracic epidural space through measurement of pressure levels. While this device is approved by the FDA for use in the procedure of the lumbar epidural, it is not used to perform the epidural procedure but rather to measure the epidural pressure. This study will likewise measure the epidural pressure.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 to 80 years inclusive
  • BMI 18.5 to 40 inclusive
  • Scheduled for thoracic epidural anesthesia

Exclusion Criteria:

  • Patients younger than 18 years or older than 80 years of age
  • Patients with BMI less than 18.5 or greater than 40
  • Contraindication to thoracic epidural anesthesia
  • Allergy or hypersensitivity to local anesthetics
  • Patients with preexisting nerve damage
  • Patients unable to provide written informed consent
  • Individuals of vulnerable populations: children, pregnant women, prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase A - Thoracic ES with LOR
Patients will receive thoracic epidural anesthesia. The thoracic epidural needle will be introduced until loss of resistance (LOR) is perceived to identify the thoracic epidural space (ES). The Compuflo Epidural Instrument will be used to record pressure readings. The thoracic epidural procedure will then continue per standard of care.
Device: Compuflo Epidural Instrument
Compuflo Epidural Instrument will be used to measure pressure levels in the thoracic epidural space while performing thoracic epidural anesthesia.
Experimental: Phase B - Thoracic ES with Compuflo
Patients will receive thoracic epidural anesthesia. The thoracic epidural needle will be introduced until the Compuflo Epidural Instrument indicates that pressure has decreased. The loss of resistance technique will then be used to identify the thoracic epidural space. The thoracic epidural procedure will then continue per standard of care.
Device: Compuflo Epidural Instrument
Compuflo Epidural Instrument will be used to measure pressure levels in the thoracic epidural space while performing thoracic epidural anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure Levels in Thoracic Epidural Space
Time Frame: Day 1
The Compuflo Epidural Instrument measures the pressure levels in millimeters of mercury (mmHg) in the thoracic epidural space
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Successful Performance of Thoracic Epidural Anesthesia Using Loss of Resistance Technique
Time Frame: Day 1
Percent of thoracic epidural anesthesia procedures using LOR that result in a loss of sensation to cold in at least one dermatome, either unilateral or bilateral
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Ralf E Gebhard, MD, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2018

Primary Completion (Actual)

July 17, 2018

Study Completion (Actual)

July 17, 2018

Study Registration Dates

First Submitted

December 12, 2017

First Submitted That Met QC Criteria

December 12, 2017

First Posted (Actual)

December 18, 2017

Study Record Updates

Last Update Posted (Actual)

December 3, 2020

Last Update Submitted That Met QC Criteria

November 10, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20170665

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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