Epidural Waveforms: Pressure Transducer vs CompuFlo

March 22, 2022 updated by: European e-Learning School in Obstetric Anesthesia

Reliability of Pressure Waveform Analysis to Determine Correct Epidural Catheter Placement; a Comparison Between Pressure Transducer and the CompuFlo® CathCheck™ System

The purpose of this single arm, open label study will be to compare and evaluate the sensitivity and specificity of CompuFlo to detect epidural pulse waveforms (EPW) to assess the correct placement of the catheter in the epidural space when compared to the standard pressure transducer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

40 patients who had an epidural functioning catheter previously positioned for anesthesia or analgesia will be enrolled. After removing the epidural filter and after having zeroed the instrument, the investigator will connect in a random fashion sequence, a standard pressure transducer attached to a standard invasive blood pressure monitor or to the CompuFlo CathCheck instrument to observe and record the occurrence of epidural pulsatile waveform.

The investigator will also note and evaluate:

The volume of saline priming necessary to obtain the waveform The effects of patient's position on the occurrence and amplitude of epidural pulsatile waveform

Study Type

Interventional

Enrollment (Actual)

40

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

  • Italy
      • Roma, Italy, 00151
        • Citta di Roma 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:

  • patients with an epidural lumbar catheter for anesthesia or analgesia

Exclusion Criteria:

  • patients with malfunction or dislodgement of the epidural catheter

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: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Standard Pressure Transducer
Epidural pressure waveforms will be measured by using a standard invasive monitor pressure transducer
Device: CompuFlo
The occurrence of epidural pulse waves with CompuFlo and with standard pressure trnsducer
Other Names:
  • Standard Pressure Transducer
ACTIVE_COMPARATOR: CompuFlo
Epidural pressure waveforms will be measured by using the CompuFlo Instrument
Device: CompuFlo
The occurrence of epidural pulse waves with CompuFlo and with standard pressure trnsducer
Other Names:
  • Standard Pressure Transducer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulse Wave
Time Frame: up to 15 minutes
Occurrence of epidural pulse wave
up to 15 minutes

Collaborators and Investigators

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

Sponsor

European e-Learning School in Obstetric Anesthesia

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 1, 2020

Primary Completion (ACTUAL)

April 30, 2021

Study Completion (ACTUAL)

April 30, 2021

Study Registration Dates

First Submitted

January 18, 2020

First Submitted That Met QC Criteria

January 23, 2020

First Posted (ACTUAL)

January 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 23, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • EESOA5

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.

Yes

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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