Effect of Extended Infusion Lines on Pulse Contour-based Measurements

Status Completed

Clinical Trial Summary

Hemodynamic monitoring of the critically-ill patients is increasingly performed using an arterial pulse contour-based cardiac output device such as the proAQT system.

The aim of this study is to evaluate the effect of extending the pressure lines on the arterial pressure wave and the calculated hemodynamic variables when using the proAQT system.

Clinical Trial Description

Hemodynamic continuous monitoring of critically-ill patients is increasingly performed with minimally-invasive methods, such as the proAQT sensor (PULSION Medical Systems SE, Munich, Germany).

The proAQT sensor calculates hemodynamic variables such as the cardiac output, stroke volume (variation), pulse-pressure variation and systemic vascular resistance by pulse contour analysis of the arterial pressure waveform using an arterial radial or femoral catheter. This minimal invasive technique, also permits continuous beat-to-beat assessment.

In patients in who an arterial catheter is placed for clinical reasons, the hemodynamic variables are continuously recorded. An extension line is coupled to a 3-way stopcock, connected to the proAQT sensor. In a neutral position of the 3-way stopcock, the pressure wave travels from the pressure sensor through the standard line. By turning the handle of the stopcock the standard line is bypassed and the pressure wave travels through the extended line.

The hemodynamic registration will be as follows:

- two minutes in the neutral position;

- two minutes with one type of extension line

- two minutes in the neutral position

- two minutes with a second type of extension line

- two minutes in neutral position

The arterial pressure curve and all calculated hemodynamic variables are electronically registered.

The influence of two types of extension lines on the accuracy of the calculated hemodynamic variables will be evaluated by comparing the variables measured in neutral position and variables measured with the extended pressure lines. The changes in the calculated variables will be correlated to possible arterial pressure waveform modifications and used to evaluate different algorithms, which might be used to reconstruct the primary pressure wave. ;

Study Design

Related Conditions & MeSH terms

Hemodynamic Instability

Clinical Trial Details

NCT number	NCT03599440
Study type	Observational
Source	Algemeen Ziekenhuis Maria Middelares
Contact
Status	Completed
Phase
Start date	September 15, 2018
Completion date	December 30, 2018

View Details

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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.