Non-Invasive CVP Method to Standard CVP Method

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Central Venous Pressure

Clinical Trial Details

NCT number	NCT03705299
Study type	Interventional
Source	The Cooper Health System
Contact
Status	Completed
Phase	N/A
Start date	November 12, 2012
Completion date	April 6, 2018

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT01116973` - Reliability of Central Venous Pressure Measurements	N/A
Recruiting	`NCT05411263` - Portal Vein Flow Variability to Quantify Right-Sided Hemodynamic Congestion (PORTAL)	N/A
Completed	`NCT00904358` - Estimation of Internal Jugular Vein Central Venous Pressure (CVP) by Ultrasound	N/A
Completed	`NCT05476666` - Peripheral Venous Pressure as an Indicator of Central Venous Pressure in Post Operative Surgical Patients: A Randomised Controlled Trial	N/A
Not yet recruiting	`NCT06237751` - Preoperative Sildenafil Administration for Hepatectomy	N/A
Completed	`NCT03423420` - Pontos-Central Venous Pressure and Cardiac Surgery
Completed	`NCT04596332` - Central Venous Pressure Monitoring and Prognosis of High-risk Operating Patients
Completed	`NCT01099241` - Central Venous Pressure (CVP) Assessment by Ultrasound and Physical Examination	N/A
Completed	`NCT01099254` - Internal Jugular Vein Cross Sectional Area
Terminated	`NCT03160742` - Pilot Study of a Non-Invasive Central Venous Pressure Monitoring System in Children
Completed	`NCT01574690` - Correlation of Physical Exam Versus Non-invasive Assessment Versus Invasive Assessment of Central Venous Pressure	N/A
Completed	`NCT01117883` - Sternal Wall Pressure in the Cath Lab	N/A
Withdrawn	`NCT01243515` - Comparison of a Non-Invasive Central Venous Pressure Device and Physical Examination in Patients With Chronic Kidney Disease	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.