Hemodynamic InstabilityNCT03599440
Effect of Extended Infusion Lines on Pulse Contour-based Measurements
An observational study of Hemodynamic Instability, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- Pressure line extensions
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Sep 2018to 30 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult hospitalized patients for which arterial pressure measurement is needed.
Who may be able to join
- ASA 1-2
- arterial catheter necessary for clinical reasons
Who cannot join
- ≥ASA 3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Pressure line extensions
- Keywords
- cardiac output, pulse contour analysis, stroke volume, hemodynamic monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure line extensionsOther
Two types of extension lines are connected:
- Perfusor® line 150cm (polyethylene)
- conventional arterial extension line
| Study group | Role | What they receive |
|---|---|---|
| Pulse contour disturbance | Patients with an arterial catheter and pressure line extensions. Receives: Other: Pressure line extensions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
The relative chane in AUC of the arterial pressure curve (from start systole to dicrotic notch) following increase in length of the extension line.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: one minute of measurement after changing the length of the extension line.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start15 Sep 2018
- Primary completion15 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Algemeen Ziekenhuis Maria Middelares
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Alain Kalmar, MD, PhD, Algemeen Ziekenhuis Maria Middelares
- Investigators
- Alain Kalmar, MD, PhD, MSc, Principal investigator, Maria Middelares Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599440
- Sponsor's protocol ID
- MMS.2018.004
- Status last verified
- Oct 2019
- First submitted
- 20 Jun 2018
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Different Types of Extended Infusion Lines on Pulse Contour-based Measurements Based on the Arterial Pressure Signal
- ClinicalTrials.gov ID
- NCT03599440
- Acronym / sponsor ID
- MMS.2018.004
- Conditions
- Hemodynamic Instability
- Keywords
- cardiac output, pulse contour analysis, stroke volume, hemodynamic monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Algemeen Ziekenhuis Maria MiddelaresUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulse contour disturbance | – | Other: Pressure line extensionsPatients with an arterial catheter and pressure line extensions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult hospitalized patients for which arterial pressure measurement is needed.
Key inclusion criteria (2 listed)
- ASA 1-2
- arterial catheter necessary for clinical reasons
Key exclusion criteria (1 listed)
- ≥ASA 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure line extensionsTwo types of extension lines are connected: * Perfusor® line 150cm (polyethylene) * conventional arterial extension line | Other | Pulse contour disturbance |
Primary outcome
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.
6 secondary outcomes
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.
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 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 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 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 ProAQT-calculated pulse pressure variation after placement of extension lines.
Time frame: one minute of measurement after changing the length of the extension line.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Kalmar, MD, PhD, MSc principal investigator
Maria Middelares Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamic Instability, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.