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Epidural Pressure Waveform Recordings by the CompuFlo® Cath-Checker System

NCT04240912 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2021-02-03

No results posted yet for this study

Summary

The purpose of this single arm, open label study will be to evaluate whether the dwell time of the epidural catheter, patients' position, the presence of active labor contractions and the priming volume of the epidural catheter may affect the sensitivity and specificity of CompuFlo to detect epidural pulse waveforms (EPW) to assess the correct placement of the catheter in the epidural space.

Conditions

  • Anesthesia, Epidural

Interventions

DEVICE

CompuFlo Epidural Computer Controlled System

The CompuFlo Epidural Instrument allows the objective identification of the epidural space by pressure measurement at the needle tip and consequently enables the physician to perform epidural anesthesia and epidural injections using standard methods. However, for the purpose of this study the instrument will be used only as a monitor to detect the occurrence of EPW. The CompuFlo Epidural Computer Controlled Anesthesia System has received a CE mark in the European Union and it received 510(k) clearance from the FDA in June 2017.

Sponsors & Collaborators

  • European e-Learning School in Obstetric Anesthesia

    lead OTHER

Principal Investigators

  • Giorgio Capogna, MD · European e-Learning School in Obstetric Anesthesia

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-28
Primary Completion
2020-09-30
Completion
2020-09-30
FDA Device
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04240912 on ClinicalTrials.gov