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

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.

Study Overview

• Status: Completed
• Conditions: Hemodynamic Instability
• Intervention / Treatment: Other: Pressure line extensions

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.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Belgium
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • AZ Maria Middelares

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult hospitalized patients for which arterial pressure measurement is needed.

Description

Inclusion Criteria:

• ASA 1-2
• arterial catheter necessary for clinical reasons

Exclusion Criteria:

• ≥ASA 3

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pulse contour disturbance; Patients with an arterial catheter and pressure line extensions.	Other: Pressure line extensions; Two types of extension lines are connected: Perfusor® line 150cm (polyethylene); conventional arterial extension line

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Algemeen Ziekenhuis Maria Middelares
• Investigators: Principal Investigator: Alain Kalmar, MD, PhD, MSc, Maria Middelares Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2018
• Primary Completion (Actual): December 15, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: June 20, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): October 10, 2019
• Last Update Submitted That Met QC Criteria: October 9, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: cardiac output; hemodynamic monitoring; stroke volume; pulse contour analysis
• Other Study ID Numbers: MMS.2018.004

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: No