Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-03-27 @ 2:07 AM
Study NCT ID:
NCT04202432
Status:
COMPLETED
Last Update Posted:
2019-12-18
First Post:
2019-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Validation of Algorithms for Mean Systemic Filling Pressure and Automated Cardiac Output
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012770', 'term': 'Shock, Cardiogenic'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D020896', 'term': 'Hypovolemia'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D011293', 'term': 'Premenstrual Syndrome'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-17', 'studyFirstSubmitDate': '2019-12-16', 'studyFirstSubmitQcDate': '2019-12-16', 'lastUpdatePostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical validation of Pms-algorithm', 'timeFrame': 'Hours', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Correlation invasive continuous cardiac output and 3D-TOE / carotid artery pulsed wave CO measurement.', 'timeFrame': 'Hours', 'description': 'Correlation between invasively measured continuous cardiac output (CO) and CO measured by a automated 3D-TOE algorithm and carotid artery PW-measured CO.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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'], 'conditions': ['Shock, Cardiogenic', 'Shock Hypovolemic', 'Hypovolemia', 'Cardiac Failure']}, 'referencesModule': {'references': [{'pmid': '33791920', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Background of the study:\n\nVolume-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.\n\nObjective of the study:\n\n1. Is there a good correlation between Pms-Nav and Pms-Insp?\n2. 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?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing coronary artery bypass grafting with a good left and right ventricular ejection fraction, no significant valvular insufficiencies/stenoses and no significant comorbidity.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Good left and right ventricular ejection fraction\n* No significant valvular insufficiencies/stenoses\n* No significant comorbidity\n* Signed informed consent\n* Elective coronary artery bypass surgery\n* Postoperative mechanically ventilated admitted to the PACU\n\nExclusion Criteria:\n\n* Withdrawal informed consent\n* History of pneumonectomy of lobectomy\n* Mechanical support of circulation\n* COPD Gold 3 or 4\n* Complications during surgery\n* Postoperative bleeding \\>50mL/15 minutes after admission to PACU - No thoracic drain in pleura\n* Postoperative pneumothorax\n* Participation in other research studies/trials\n* Elevated intra-abdominal surgery (\\>12 mmHg)'}, 'identificationModule': {'nctId': 'NCT04202432', 'acronym': 'PP3D', 'briefTitle': 'Clinical Validation of Algorithms for Mean Systemic Filling Pressure and Automated Cardiac Output', 'organization': {'class': 'OTHER', 'fullName': 'Catharina Ziekenhuis Eindhoven'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'NL67389.100.18'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Coronary Artery Bypass Surgery patients', 'description': 'Patients undergoing coronary artery bypass surgery (on-pump / off-pump) measured perioperatively and postoperatively.', 'interventionNames': ['Diagnostic Test: Mean systemic filling pressure']}], 'interventions': [{'name': 'Mean systemic filling pressure', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Measurement of cardiac output'], 'description': 'Peri- and postoperative measurement of continuous cardiac output with thermodilution derived pulse contour calculated device (PiCCO).\n\nEstimation 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.', 'armGroupLabels': ['Coronary Artery Bypass Surgery patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5623 EJ', 'city': 'Eindhoven', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'Catharina Hospital', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}], 'overallOfficials': [{'name': 'LPB Meijs, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Catharina Ziekenhuis Eindhoven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catharina Ziekenhuis Eindhoven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiologist, fellow intensive care medicine, PhD candidate Intensive Care Medicine', 'investigatorFullName': 'L.P.B. Meijs', 'investigatorAffiliation': 'Catharina Ziekenhuis Eindhoven'}}}}