NCT04240197

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

March 23, 2022

Status Verified

January 1, 2021

Enrollment Period

10 months

First QC Date

January 18, 2020

Last Update Submit

March 22, 2022

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Pulse Wave

    Occurrence of epidural pulse wave

    up to 15 minutes

Study Arms (2)

Standard Pressure Transducer

SHAM COMPARATOR

Epidural pressure waveforms will be measured by using a standard invasive monitor pressure transducer

Device: CompuFlo

CompuFlo

ACTIVE COMPARATOR

Epidural pressure waveforms will be measured by using the CompuFlo Instrument

Device: CompuFlo

Interventions

CompuFloDEVICE

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

Also known as: Standard Pressure Transducer
CompuFloStandard Pressure Transducer

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with an epidural lumbar catheter for anesthesia or analgesia

You may not qualify if:

  • patients with malfunction or dislodgement of the epidural catheter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Città di Roma Hospital

Roma, 00151, Italy

Location

Related 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.

    PMID: 30482001BACKGROUND

Study Officials

  • Giorgio Capogna, MD

    European e-Learning School in Obstetric Anesthesia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2020

First Posted

January 27, 2020

Study Start

July 1, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

March 23, 2022

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)