Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-02-21 @ 4:00 AM
Study NCT ID:
NCT02529033
Status:
COMPLETED
Last Update Posted:
2023-05-16
First Post:
2015-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodynamic Survey Cardiac Surgical Scenarios
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002303', 'term': 'Cardiac Output, Low'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-12', 'studyFirstSubmitDate': '2015-08-03', 'studyFirstSubmitQcDate': '2015-08-18', 'lastUpdatePostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To expect difference is within 1 unit ( scale of 1 to 5) in the hemodynamic assessment preferably preload , afterload and contractility between Lidco and data from PA catheter in different cardiac surgical patient scenarios.', 'timeFrame': 'intraoperative'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Low Cardiac Output']}, 'referencesModule': {'references': [{'pmid': '21092290', 'type': 'BACKGROUND', 'citation': 'Hadian M, Kim HK, Severyn DA, Pinsky MR. Cross-comparison of cardiac output trending accuracy of LiDCO, PiCCO, FloTrac and pulmonary artery catheters. Crit Care. 2010;14(6):R212. doi: 10.1186/cc9335. Epub 2010 Nov 23.'}, {'pmid': '21356060', 'type': 'BACKGROUND', 'citation': 'Broch O, Renner J, Hocker J, Gruenewald M, Meybohm P, Schottler J, Steinfath M, Bein B. Uncalibrated pulse power analysis fails to reliably measure cardiac output in patients undergoing coronary artery bypass surgery. Crit Care. 2011;15(1):R76. doi: 10.1186/cc10065. Epub 2011 Feb 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out the Lidco Rapid ( monitoring tool gives cardiac output) is as equivalent in determining the hemodynamic assessment in cardiac surgical scenarios as the most often used pulmonary artery catheter, which is much more invasive than the Lidco Rapid. This will be accomplished through online surveys which have different cardiac surgery scenarios and will be distributed to cardiac fellowship trained anesthesiologists. The online based survey will include a specific scenario and details on the scenario represented in image format and a brief description of the patient to aid with their analysis of the situation.', 'detailedDescription': 'Data from PA catheter such as PA pressure, pulmonary wedge pressure and cardiac output has been widely used in the various clinical situations warranting advance hemodynamic monitoring. It is considered as gold standard but unfortunately there is always risk associated with PA catheter and time lag between the clinical events and interpretation. Lidco Rapid is one of the non-invasive hemodynamic tools to measure various parameters. It is widely used in the intensive care set up for goal directed therapy but unfortunately there is not enough data to show whether it is useful in various peri-operative clinical conditions. In the online based survey, responses from the participants are recorded in the nominal scale ( 1 to 5 where 3 represents near normal). This survey will help to determine whether Investigators can replace the Lidco in any clinical situation warranting advance hemodynamic monitoring.\n\nNo previous study was done to specifically find out the hemodynamic component that differs between these tools intraoperatively in varying hemodynamic conditions during cardiac surgery although there were few studies compared the trend in the cardiac output with difference in opinion on their accuracy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '28 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cardiac Fellowship trained Anesthesiologists', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be a certified Anesthesiologist with cardiac fellowship training\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT02529033', 'briefTitle': 'Hemodynamic Survey Cardiac Surgical Scenarios', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Comparative Hemodynamic Assessment Between Lidco Rapid and Pulmonary Artery Thermodilution', 'orgStudyIdInfo': {'id': '201504777'}}, 'armsInterventionsModule': {'interventions': [{'name': 'LIDCO Rapid, Pulmonary artery catheter', 'type': 'DEVICE', 'description': 'Hemodynamic monitoring systems'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sudhakar Subramani, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Iowa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}