Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2026-02-10 @ 11:55 PM
Study NCT ID:
NCT01744795
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2012-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CardioQ vs Thermodilution Measurements of Cardiac Output
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006439', 'term': 'Hemodynamics'}], 'ancestors': [{'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-17', 'studyFirstSubmitDate': '2012-12-04', 'studyFirstSubmitQcDate': '2012-12-05', 'lastUpdatePostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Agreement of cardiac output determined with CardioQ, compared with thermodilution', 'timeFrame': 'Data are collected in the perioperative period (30min.)', 'description': 'Data are collected for each patient in the perioperative period. Patients are followed in the first 24 hours. Data will after inclusion of the last data be analysed and appropiate statistics aplied.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cardiac output', 'thermodilution', 'esophageal doppler', 'trending ability'], 'conditions': ['Comparison of CardioQ and Thermodilution Derived Cardiac Output Measurements']}, 'descriptionModule': {'briefSummary': 'Minimal invasive monitoring systems of central hemodynamics are gaining increasing popularity. The present study investigates the precision of the esophageal doppler (CardioQ) derived cardiac output and its agreement with pulmonary artery catheter thermodilution (PAC TD) for measuring CO during steady state and with induced hemodynamic changes in patients scheduled for elective cardiac surgery.', 'detailedDescription': 'Twenty-five patients are planned to be enrolled. After induction of anesthesia, insertion of the PAC and the esophageal-doppler probe, the patient are placed in the following successive positions: a) supine, b) head-down tilt, c) head-up tilt, d) supine, e) supine with phenylephrine administration f) pace heart rate 80 bpm, g) pace heart rate 110 bpm, and CO are measured simultaneously using the CardioQ and PAC TD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients scheduled for elective coronary artery bypass grafting (CABG), who are in stable sinus rhythm, who have a left ventricular ejection fraction \\> 0.40 measured by transthoracic echocardiography, and who have no significant valve pathology\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01744795', 'briefTitle': 'CardioQ vs Thermodilution Measurements of Cardiac Output', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Comparison of CardioQ and Pulmonary Artery Thermodilution Derived Cardiac Output Measurements', 'orgStudyIdInfo': {'id': 'H-3-2012-063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'induced changes in hemodynamics', 'description': 'Twenty-five patients are planned enrolled. After induction of anesthesia, insertion of the PAC and the CardioQ probe, the patient are placed in the following successive positions: a) supine, b) head-down tilt, c) head-up tilt, d) supine, e) supine with phenylephrine administration f) pace heart rate 80 bpm, g) pace heart rate 110 bpm. CO are measured simultaneously using the CardioQ and thermodilution technique.', 'interventionNames': ['Other: induced changes in hemodynamics']}], 'interventions': [{'name': 'induced changes in hemodynamics', 'type': 'OTHER', 'description': 'Twenty-five patients are planned enrolled. After induction of anesthesia, insertion of the PAC and the CardioQ probe, the patient are placed in the following successive positions: a) supine, b) head-down tilt, c) head-up tilt, d) supine, e) supine with phenylephrine administration f) pace heart rate 80 bpm, g) pace heart rate 110 bpm. CO are measured simultaneously using the TEE and thermodilution technique.', 'armGroupLabels': ['induced changes in hemodynamics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Capital Region', 'country': 'Denmark', 'facility': 'Rigshospitalet, University of Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Cardiothoracic anesthesiology; Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasse Moller-Sorensen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Hasse Moller-Sorensen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}