Effect of Extended Infusion Lines on Pulse Contour-based Measurements

Hemodynamic Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599440
• Other study ID #: MMS.2018.004
• Status: Completed
• Start date: September 15, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: October 2019
• Source: Algemeen Ziekenhuis Maria Middelares
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 30, 2018
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ASA 1-2

• arterial catheter necessary for clinical reasons

Exclusion Criteria:

• =ASA 3

Related Conditions & MeSH terms

• Hemodynamic Instability

Intervention

Other:
• Pressure line extensions
Two types of extension lines are connected: Perfusor® line 150cm (polyethylene) conventional arterial extension line

Locations

Country	Name	City	State
Belgium	AZ Maria Middelares	Ghent	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
Algemeen Ziekenhuis Maria Middelares

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relative change in ProAQT-calculated cardiac output after placement of extension lines.	relative change (in % of the baseline measurement) in cardiac output following increase in length of the extension line.	one minute of measurement after changing the length of the extension line.
Secondary	change in Area Under the Curve (AUC) of the arterial pressure wave form after placement of extension lines.	The relative chane in AUC of the arterial pressure curve (from start systole to dicrotic notch) following increase in length of the extension line.	one minute of measurement after changing the length of the extension line.
Secondary	relative change in ProAQT-calculated SVR after placement of extension lines.	relative change (in % of the baseline measurement) in systemic vascular resistance following increase in length of the extension line.	one minute of measurement after changing the length of the extension line.
Secondary	relative change in ProAQT-calculated diastolic blood pressure after placement of extension lines.	relative change (in % of the baseline measurement) in diastolic blood pressure following increase in length of the extension line.	one minute of measurement after changing the length of the extension line.
Secondary	relative change in ProAQT-calculated systolic blood pressure after placement of extension lines.	relative change (in % of the baseline measurement) in systolic blood pressure following increase in length of the extension line.	one minute of measurement after changing the length of the extension line.
Secondary	relative change in ProAQT-calculated stroke volume variation after placement of extension lines.	relative change (in % of the baseline measurement) in stroke volume variation following increase in length of the extension line.	one minute of measurement after changing the length of the extension line.
Secondary	relative change in ProAQT-calculated pulse pressure variation after placement of extension lines.	relative change (in % of the baseline measurement) in pulse pressure variation following increase in length of the extension line.	one minute of measurement after changing the length of the extension line.