Clinical Trials Directory

Trials / Completed

CompletedNCT03599440

Effect of Extended Infusion Lines on Pulse Contour-based Measurements

Evaluation of the Effect of Different Types of Extended Infusion Lines on Pulse Contour-based Measurements Based on the Arterial Pressure Signal

Status
Completed
Phase
Study type
Observational
Enrollment
10 (actual)
Sponsor
Algemeen Ziekenhuis Maria Middelares · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHERPressure line extensionsTwo types of extension lines are connected: * Perfusor® line 150cm (polyethylene) * conventional arterial extension line

Timeline

Start date
2018-09-15
Primary completion
2018-12-15
Completion
2018-12-30
First posted
2018-07-26
Last updated
2019-10-10

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT03599440. Inclusion in this directory is not an endorsement.