Shock, CardiogenicPP3DNCT04202432
Clinical Validation of Algorithms for Mean Systemic Filling Pressure and Automated Cardiac Output
An observational study of Shock, Cardiogenic and Shock Hypovolemic, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
Prospective combined clinical validation of an algorithmic calculated mean systemic filling pressure (Pms-Nav) with the gold standard for Pms (Pms calculated from venous return curves during inspiratory hold procedures with incremental airway pressures; Pms-Insp). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Cardiogenic, Shock Hypovolemic, Hypovolemia
- What is being tested?
- Mean systemic filling pressure
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Jun 2019to 30 Aug 2019
- 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: Patients undergoing coronary artery bypass grafting with a good left and right ventricular ejection fraction, no significant valvular insufficiencies/stenoses and no significant comorbidity.
Who may be able to join
- Good left and right ventricular ejection fraction
- No significant valvular insufficiencies/stenoses
- No significant comorbidity
- Signed informed consent
- Elective coronary artery bypass surgery
- Postoperative mechanically ventilated admitted to the PACU
Who cannot join
- Withdrawal informed consent
- History of pneumonectomy of lobectomy
- Mechanical support of circulation
- COPD Gold 3 or 4
- Complications during surgery
- Postoperative bleeding >50mL/15 minutes after admission to PACU - No thoracic drain in pleura
Show all 9Show fewer
- Postoperative pneumothorax
- Participation in other research studies/trials
- Elevated intra-abdominal surgery (>12 mmHg)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PP3D - Prospective Combined Validation of an Algorithm for Measurement of Mean Systemic Filling Pressure and Comparison of Invasively Measured Cardiac Output Versus Cardiac Output Calculated by 3D TOE and Carotid Ultrasound.
Prospective combined clinical validation of an algorithmic calculated mean systemic filling pressure (Pms-Nav) with the gold standard for Pms (Pms calculated from venous return curves during inspiratory hold procedures with incremental airway pressures; Pms-Insp). Secondary correlation between invasive cardiac output measurement versus 3D TOE and carotid echo doppler measured cardiac output.
Read the detailed description
Background of the study:
Volume-state in critically ill patients is a difficult parameter to determine, and knowledge about it could make the difference between life or death concerning proper treatment. Determination of volume state starts with adequate 3D transesophageal echocardiography (TOE) in the operation room, including with non-invasive doppler carotid artery measures. TOE is a standardly used method in cardiac surgery. Because echocardiography only gives information about volume status at a certain timepoint, a real-time continuous value reflecting volume-status is needed. "Mean systemic filling pressure (Pms)" appears to be a promising value reflecting volume status. There is a reliable, but cumbersome method available which to date serves as a gold standard to determine Pms (Pms calculated by constructing venous return curves during incremental levels of airway pressure, thereby simulating a decrease in preload --> Pms-Insp). However, this method cannot be used in daily clinical practice because it is laborious and cumbersome. Therefore there is a need for a non-invasive methods measuring Pms, which could now be determined by a computerized algorithm with the Navigator-device (Pms-Nav). It is key to compare this Pms-Nav with its gold standard (Pms-Insp) in order to establish a clinical validation for Pms-Nav.
Objective of the study:
- Is there a good correlation between Pms-Nav and Pms-Insp?
- Is there a good correlation between invasive continuous cardiac output measurement (by thermodilution and pulse-contour analyse detected by the PiCCO-device) and 3D transoesophageal echocardiography (TOE) and carotid echo doppler?
- Conditions
- Shock, Cardiogenic, Shock Hypovolemic, Hypovolemia, Cardiac Failure
- Being tested
- Mean systemic filling pressure
- Keywords
- Mean Systemic Filling Pressure, Pms, Pmsf, Hypovolemia, Cardiac Output, Transpulmonary thermodilution, Transesophageal echocardiography, Volume state, Critical Care, Cardiosurgery, Intensive Care, Carotid ultrasound, Pulsed Wave, Inspiratory breath hold
- Medical subject headings
- Shock, Cardiogenic, Shock, Hypovolemia, Heart Failure, Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mean systemic filling pressureDiagnostic test
Also called Measurement of cardiac output
Peri- and postoperative measurement of continuous cardiac output with thermodilution derived pulse contour calculated device (PiCCO).
Estimation of mean systemic filling pressure using a computerized algorithm and by creating venous return curves with inspiratory hold maneuvers, thereby extrapolating the VR-curve until mean systemic filling pressure is calculated.
| Study group | Role | What they receive |
|---|---|---|
| Coronary Artery Bypass Surgery patients | Patients undergoing coronary artery bypass surgery (on-pump / off-pump) measured perioperatively and postoperatively. Receives: Diagnostic Test: Mean systemic filling pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical validation of Pms-algorithm
To determine a correlation between Pms calculated by a computerized algorithm by Navigator(TM) (Pms-Nav) and the gold standard for determining Pms: Pms-Insp. The latter is calculated by performing inspiratory breath holds during incremental airway pressure levels thereby simulating a decrease in preload which, by extrapolating a venous return curve, leads to the true Pms when the curve intersects the x-axis (Pms-Insp).
Measured: Hours
Secondary outcomes (1)
Correlation invasive continuous cardiac output and 3D-TOE / carotid artery pulsed wave CO measurement.
Correlation between invasively measured continuous cardiac output (CO) and CO measured by a automated 3D-TOE algorithm and carotid artery PW-measured CO.
Measured: Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start24 Jun 2019
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shock, CardiogenicStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, L.P.B. Meijs, Catharina Ziekenhuis Eindhoven
- Investigators
- LPB Meijs, MD, Principal investigator, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202432
- Sponsor's protocol ID
- NL67389.100.18
- Acronym
- PP3D
- Status last verified
- Dec 2019
- First submitted
- 16 Dec 2019
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing
Publications
Meijs LPB, van Houte J, Conjaerts BCM, Bindels AJGH, Bouwman A, Houterman S, Bakker J. Clinical validation of a computerized algorithm to determine mean systemic filling pressure. J Clin Monit Comput. 2022 Feb;36(1):191-198. doi: 10.1007/s10877-020-00636-2. Epub 2021 Mar 31.
PubMed 33791920
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PP3D - Prospective Combined Validation of an Algorithm for Measurement of Mean Systemic Filling Pressure and Comparison of Invasively Measured Cardiac Output Versus Cardiac Output Calculated by 3D TOE and Carotid Ultrasound.
- ClinicalTrials.gov ID
- NCT04202432
- Acronym / sponsor ID
- PP3D / NL67389.100.18
- Conditions
- Shock, Cardiogenic, Shock Hypovolemic, Hypovolemia, Cardiac Failure
- Keywords
- Mean Systemic Filling Pressure, Pms, Pmsf, Hypovolemia, Cardiac Output, Transpulmonary thermodilution, Transesophageal echocardiography, Volume state
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 17 Dec 2019 (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.
Prospective combined clinical validation of an algorithmic calculated mean systemic filling pressure (Pms-Nav) with the gold standard for Pms (Pms calculated from venous return curves during inspiratory hold procedures with incremental airway pressures; Pms-Insp). Secondary correlation between invasive cardiac output measurement versus 3D TOE and carotid echo doppler measured cardiac output.
Detailed description
Background of the study:
Volume-state in critically ill patients is a difficult parameter to determine, and knowledge about it could make the difference between life or death concerning proper treatment. Determination of volume state starts with adequate 3D transesophageal echocardiography (TOE) in the operation room, including with non-invasive doppler carotid artery measures. TOE is a standardly used method in cardiac surgery. Because echocardiography only gives information about volume status at a certain timepoint, a real-time continuous value reflecting volume-status is needed. "Mean systemic filling pressure (Pms)" appears to be a promising value reflecting volume status. There is a reliable, but cumbersome method available which to date serves as a gold standard to determine Pms (Pms calculated by constructing venous return curves during incremental levels of airway pressure, thereby simulating a decrease in preload --> Pms-Insp). However, this method cannot be used in daily clinical practice because it is laborious and cumbersome. Therefore there is a need for a non-invasive methods measuring Pms, which could now be determined by a computerized algorithm with the Navigator-device (Pms-Nav). It is key to compare this Pms-Nav with its gold standard (Pms-Insp) in order to establish a clinical validation for Pms-Nav.
Objective of the study:
- Is there a good correlation between Pms-Nav and Pms-Insp?
- Is there a good correlation between invasive continuous cardiac output measurement (by thermodilution and pulse-contour analyse detected by the PiCCO-device) and 3D transoesophageal echocardiography (TOE) and carotid echo doppler?
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary Artery Bypass Surgery patients | – | Diagnostic Test: Mean systemic filling pressurePatients undergoing coronary artery bypass surgery (on-pump / off-pump) measured perioperatively and postoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing coronary artery bypass grafting with a good left and right ventricular ejection fraction, no significant valvular insufficiencies/stenoses and no significant comorbidity.
Key inclusion criteria (6 listed)
- Good left and right ventricular ejection fraction
- No significant valvular insufficiencies/stenoses
- No significant comorbidity
- Signed informed consent
- Elective coronary artery bypass surgery
Key exclusion criteria (9 listed)
- Withdrawal informed consent
- History of pneumonectomy of lobectomy
- Mechanical support of circulation
- COPD Gold 3 or 4
- Complications during surgery
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 |
|---|---|---|
| Mean systemic filling pressureAlso: Measurement of cardiac outputPeri- and postoperative measurement of continuous cardiac output with thermodilution derived pulse contour calculated device (PiCCO). Estimation of mean systemic filling pressure using a computerized algorithm and by creating venous return curves with inspiratory hold maneuvers, thereby extrapolating the VR-curve until mean systemic filling pressure is calculated. | Diagnostic test | Coronary Artery Bypass Surgery patients |
Primary outcome
Clinical validation of Pms-algorithm
Time frame: Hours
To determine a correlation between Pms calculated by a computerized algorithm by Navigator(TM) (Pms-Nav) and the gold standard for determining Pms: Pms-Insp. The latter is calculated by performing inspiratory breath holds during incremental airway pressure levels thereby simulating a decrease in preload which, by extrapolating a venous return curve, leads to the true Pms when the curve intersects the x-axis (Pms-Insp).
1 secondary outcome
Correlation invasive continuous cardiac output and 3D-TOE / carotid artery pulsed wave CO measurement.
Time frame: Hours
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 18 Dec 2019.
- Derived from this study: PubMed 33791920Meijs LPB, van Houte J, Conjaerts BCM, Bindels AJGH, Bouwman A, Houterman S, Bakker J. Clinical validation of a computerized algorithm to determine mean systemic filling pressure. J Clin Monit Comput. 2022 Feb;36(1):191-198. doi: 10.1007/s10877-020-00636-2. Epub 2021 Mar 31.
- Individual participant dataSharing planned: No. No sharing
Related trials for Shock, Cardiogenic
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
Not yet recruitingObservational study
Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
Cardiogenic Shock, Pulmonary Edema Cardiac Cause
Not yet recruitingPhase 4
Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
Recruiting
CRP Apheresis in Infarct-Related Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction (AMI)
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
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.
LPB Meijs, MD principal investigator
Catharina Ziekenhuis Eindhoven
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 Shock, Cardiogenic and Shock Hypovolemic, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
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 6 inclusion and 9 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 18 Dec 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 Netherlands. 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?
Clinical validation of Pms-algorithm (time frame: Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04202432, which also lists 1 linked publication.
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 18 Dec 2019.