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NCT04240197 Clinical Trial

Epidural Waveforms: Pressure Transducer vs CompuFlo

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04240197
Other study ID # EESOA5
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2020
Est. completion date April 30, 2021

Study information
Verified date January 2021
Source European e-Learning School in Obstetric Anesthesia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date April 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - patients with an epidural lumbar catheter for anesthesia or analgesia Exclusion Criteria: - patients with malfunction or dislodgement of the epidural catheter

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CompuFlo
The occurrence of epidural pulse waves with CompuFlo and with standard pressure trnsducer

Locations
Country Name City State
Italy Città di Roma Hospital Roma

Sponsors (1)
Lead Sponsor Collaborator
European e-Learning School in Obstetric Anesthesia

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Hilber ND, Rijs K, Klimek M, Saenz G, Aloweidi A, Rossaint R, Heesen M. A systematic review of the diagnostic accuracy of epidural wave form analysis to identify the epidural space in surgical and labor patients. Minerva Anestesiol. 2019 Apr;85(4):393-400. doi: 10.23736/S0375-9393.18.13089-6. Epub 2018 Nov 22. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pulse Wave Occurrence of epidural pulse wave up to 15 minutes
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