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
1 other identifier
observational
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2018
CompletedFirst Posted
Study publicly available on registry
July 26, 2018
CompletedStudy Start
First participant enrolled
September 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2018
CompletedOctober 10, 2019
October 1, 2019
3 months
June 20, 2018
October 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
change in Area Under the Curve (AUC) of the arterial pressure wave form after placement of extension lines.
one minute of measurement after changing the length of the extension line.
relative change in ProAQT-calculated SVR after placement of extension lines.
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.
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.
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.
one minute of measurement after changing the length of the extension line.
- +1 more secondary outcomes
Study Arms (1)
Pulse contour disturbance
Patients with an arterial catheter and pressure line extensions.
Interventions
Two types of extension lines are connected: * Perfusor® line 150cm (polyethylene) * conventional arterial extension line
Eligibility Criteria
Adult hospitalized patients for which arterial pressure measurement is needed.
You may qualify if:
- ASA 1-2
- arterial catheter necessary for clinical reasons
You may not qualify if:
- ≥ASA 3
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AZ Maria Middelares
Ghent, Oost-Vlaanderen, 9000, Belgium
Study Officials
- PRINCIPAL INVESTIGATOR
Alain Kalmar, MD, PhD, MSc
Maria Middelares Hospital
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Anesthesist
Study Record Dates
First Submitted
June 20, 2018
First Posted
July 26, 2018
Study Start
September 15, 2018
Primary Completion
December 15, 2018
Study Completion
December 30, 2018
Last Updated
October 10, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share