NCT04240197

Epidural Waveforms: Pressure Transducer vs CompuFlo

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: European e-Learning School in Obstetric Anesthesia · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Anesthesia

Interventions

Type	Name	Description
DEVICE	CompuFlo	The occurrence of epidural pulse waves with CompuFlo and with standard pressure trnsducer

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2020-01-27
• Last updated: 2022-03-23

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated device study