Effect of Extended Infusion Lines on Pulse Contour-based Measurements

NCT ID: NCT03599440

Last Updated: 2019-10-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-15
• Study Completion Date: 2018-12-30

Brief 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

Hemodynamic Instability

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Pulse contour disturbance

Patients with an arterial catheter and pressure line extensions.

Pressure line extensions

Intervention Type: OTHER

Two types of extension lines are connected:

• Perfusor® line 150cm (polyethylene)
• conventional arterial extension line

Interventions

Pressure line extensions

Two types of extension lines are connected:

• Perfusor® line 150cm (polyethylene)
• conventional arterial extension line

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• ≥ASA 3

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Algemeen Ziekenhuis Maria Middelares

OTHER

Sponsor Role: lead

Responsible Party

Dr. Alain Kalmar, MD, PhD

Staff Anesthesist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alain Kalmar, MD, PhD, MSc

Role: PRINCIPAL_INVESTIGATOR

Maria Middelares Hospital

Locations

AZ Maria Middelares

Ghent, Oost-Vlaanderen, Belgium

Countries

Belgium

Other Identifiers

MMS.2018.004

Identifier Type: -

Identifier Source: org_study_id