Non-Invasive CVP Method to Standard CVP Method

October 10, 2018 updated by: The Cooper Health System

A Prospective, Comparative Study to Evaluate the Accuracy of a Non-Invasive Central Venous Pressure Method to the Standard CVP Method

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Standard CVP Method

The CVP line is inserted into the internal jugular vein central venous catheter or subclavian vein catheter and threaded to the point where the superior vena cava meets the inferior vena cava prior to entry into the right atrium of the heart. The catheter is hooked to a pressure bag which is pressurized to 200 cm water. This pressure allows the infusion of about 3ml of fluid each hour but keeps the line patent. The distal tip of the CVP line is connected to a transducer and taped to the arm at a level which is in line with the heart.

Research Procedure (non-invasive CVP Method)

A physiologic data acquisition system (Zoe Medical, Topsfield MA)) will be used to monitor CVP, upper arm impedance changes, and upper arm cuff pressures.

The subject's CVP pressure transducer will be zeroed at the level of the right atrium (midaxillary line) with the use of a carpenter's level.

A tetra-polar impedance configuration will be used to measure upper arm impedance. A pair of current-injecting electrodes will be placed in positions 1 & 4 and two sensing electrodes will be placed in positions 2 & 3 (where a traditional blood pressure cuff would be positioned, overlying the brachial-axillary vein system). These leads extend from the Zoe Medical device. (Figure 1 taken from Ward et al., in press).

Electrobioimpedance will be measured in the upper portion of an upper extremity using an electrobioimpedance amplifier contained within the Zoe Medical device. A constant current source (1mA, 100kHz) will be sent through the current electrode and the voltage drop between the two sensing electrodes will be amplified.

A blood pressure cuff attached to the Zoe Medical Device will be positioned over the two sensing electrodes.

The cuff pressure will be quickly inflated to a value higher than CVP but lower than the diastolic arterial pressure (40 mm Hg) and kept at that pressure for 45-60 seconds.

At the end of the inflation hold period, release the cuff pressure valve and open to atmosphere to allow rapid self-deflation

Repeat measures 3 times in each subject for a period of 10 minutes

If the subject requires volume resuscitation, diuresis, or are administered inotropic drugs, we will reevaluate CVP with the non-invasive method during these circumstances. CVP will be measured every 1 minute to capture rapid changes in CVP. The length of time that the investigators monitor CVP will depend on the length of time required to detect changes in CVP.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NeuMeDex NICVP (Non-Invasive CVP) vs Standard CVP
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Cooper Health System

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
NeuroDx Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Irwin Gratz, DO, The Cooper Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 6, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 6, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12-121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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