NCT03705299

Brief Summary

This is a prospective, comparative, internally controlled device study that will enroll a total of 100 adult patients that require the placement of central venous catheter and CVP monitoring to assess volume status and cardiac preload.

Trial Health

100
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 Nov 2012

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

November 12, 2012

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
Last Updated

October 15, 2018

Status Verified

July 1, 2018

Enrollment Period

5.4 years

First QC Date

June 19, 2018

Last Update Submit

October 10, 2018

Conditions

Central Venous Pressure

Outcome Measures

Primary Outcomes (1)

  • Assessing if the NeuMeDx NICVP device is as effective as the standard invasive method at measuring CVP in patients that require central catheter placement and monitoring.

    The primary objective of the study is to measure the CVP using the NeuMeDx NICVP (Non-Invasive Central Venous Pressure) device. The critical endpoint is the average of the average of three CVP, by calibrated forced transducer, and NICVP measurements in mmHg over a 10-minute period in a patient in the supine position.

    6 months

Study Arms (1)

NeuMeDex NICVP (Non-Invasive CVP) vs Standard CVP

EXPERIMENTAL

Three pressure readings recorded for both NeuMeDex NICVP and central line pressure catheter over a 10 minute period.

Device: Non-Invasive CVP vs Standard CVP

Interventions

Non-Invasive CVP vs Standard CVPDEVICE
NeuMeDex NICVP (Non-Invasive CVP) vs Standard CVP

Eligibility Criteria

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

You may qualify if:

  • Patients aged ≥ 18 years
  • Require CVP monitoring in the supine position as part of routine care
  • Central venous access obtained by either internal or external jugular, or subclavian vein

You may not qualify if:

  • Patients aged \< 18 years
  • Patients who are pregnant
  • Patients that will be in the prone position
  • Central venous access obtained by the femoral vein

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Irwin Gratz, DO

    The Cooper Health System

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 19, 2018

First Posted

October 15, 2018

Study Start

November 12, 2012

Primary Completion

April 6, 2018

Study Completion

April 6, 2018

Last Updated

October 15, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share