- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03599440
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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Oost-Vlaanderen
-
Ghent, Oost-Vlaanderen, Belgium, 9000
- AZ Maria Middelares
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pulse contour disturbance
Patients with an arterial catheter and pressure line extensions.
|
Two types of extension lines are connected:
|
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.
Time Frame: one minute of measurement after changing the length of the extension line.
|
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.
Time Frame: one minute of measurement after changing the length of the extension line.
|
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.
Time Frame: one minute of measurement after changing the length of the extension line.
|
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.
Time Frame: one minute of measurement after changing the length of the extension line.
|
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.
Time Frame: one minute of measurement after changing the length of the extension line.
|
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.
Time Frame: one minute of measurement after changing the length of the extension line.
|
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.
Time Frame: one minute of measurement after changing the length of the extension line.
|
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
Investigators
- Principal Investigator: Alain Kalmar, MD, PhD, MSc, Maria Middelares Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MMS.2018.004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hemodynamic Instability
-
Johannes Gutenberg University MainzRecruiting
-
Cairo UniversityRecruitingHemodynamic InstabilityEgypt
-
Johannes Gutenberg University MainzRecruitingHemodynamic InstabilityGermany
-
Chaudhry Pervaiz Elahi Institute of CardiologyRecruitingHemodynamic InstabilityPakistan
-
University of MonastirCompleted
-
Mansoura UniversityCompleted
-
University of British ColumbiaCompletedHemodynamic InstabilityCanada
-
Inonu UniversityCompletedHemodynamic InstabilityTurkey
-
Muhammad Haroon AnwarPakistan Institute of Medical SciencesRecruiting
-
Sykehuset TelemarkUniversity of Oslo; Oslo University HospitalRecruiting
Clinical Trials on Pressure line extensions
-
Instituto Nacional de Cardiologia Ignacio ChavezJOSE CARRASCO ARTEAGA HOSPITAL FROM Ecuadorian Institute of Social SecurityUnknown
-
Parc de Salut MarUnknown
-
Hospital General Universitario ElcheUnknownVomiting, PostoperativeSpain
-
Riphah International UniversityCompleted
-
South Valley UniversityCompletedMajor Abdominal SurgeriesEgypt
-
Johns Hopkins UniversityTerminatedAtaxia-Telangiectasia (A-T)United States
-
Novartis PharmaceuticalsActive, not recruiting
-
Hamad Medical CorporationCompleted
-
University Hospital, MontpellierMinistry of Health, FranceCompletedCardiovascular DiseaseFrance