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OpenTrials
Completed

NCT Number: NCT04240197

Epidural Waveforms: Pressure Transducer vs CompuFlo

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.

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Key information

Conditions

Anesthesia

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Città di Roma Hospital

Roma, 00151, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with an epidural lumbar catheter for anesthesia or analgesia

Exclusion criteria

  • patients with malfunction or dislodgement of the epidural catheter

Treatment and study plan

CompuFlo

Device

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

Other names: Standard Pressure Transducer

Primary outcomes

  1. Pulse Wave

    Time frame: up to 15 minutes

    Occurrence of epidural pulse wave

Sponsors and collaborators

Lead sponsor

European e-Learning School in Obstetric Anesthesia

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2020
Registry last updated
Mar 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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