Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-27 @ 6:17 PM
Study NCT ID:
NCT00464750
Status:
COMPLETED
Last Update Posted:
2016-07-18
First Post:
2007-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Repeatability of Cardiac Output Measurements Dependence of Temperature of Injectate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-15', 'studyFirstSubmitDate': '2007-04-23', 'studyFirstSubmitQcDate': '2007-04-23', 'lastUpdatePostDateStruct': {'date': '2016-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-24', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiac output', 'Thermodilution'], 'conditions': ['Heart Diseases']}, 'referencesModule': {'references': [{'pmid': '25976600', 'type': 'RESULT', 'citation': 'Kirkeby-Garstad I, Tronnes H, Stenseth R, Sellevold OF, Aadahl P, Skogvoll E. The Precision of Pulmonary Artery Catheter Bolus Thermodilution Cardiac Output Measurements Varies With the Clinical Situation. J Cardiothorac Vasc Anesth. 2015 Aug;29(4):881-8. doi: 10.1053/j.jvca.2014.12.016. Epub 2014 Dec 12.'}]}, 'descriptionModule': {'briefSummary': 'This study tests the reliability of thermodilution cardiac output measurements with pulmonary artery catheters in immediate connection with heart surgery. In accordance with our clinical practice, thermal indicator injections are synchronized with respiration. The impact on measurement repeatability of spontaneous vs artificial ventilation and the effect of the injectate temperature is tested.\n\nThe study hypothesis is that when injections are synchronized with the respiration, only three injections at room temperature are needed to be within 5 % of the "true" cardiac output in mechanically ventilated patients.', 'detailedDescription': 'Bolus thermodilution cardiac output measurements by means of a pulmonary artery catheter have been a mainstay of monitoring critically ill patients for more than thirty years. Recent studies have questioned wether the traditional practice of averaging measurements from tree room temperature thermal indicator injections give sufficient precision.\n\nThis study tests the number of indicator injections necessary to be within 5 % of the "true" cardiac output (taken as the average of 16 injections) when the injection is synchronized with the respiration. The reliability of the thermodilution measurements are tested A) in sedated, artificially ventilated cardiac surgical patients and B) in the same patients when postoperatively awake and spontaneously breathing. We further compare the use of room temperature and iced thermal indicator injections.\n\nThe study hypothesis is that when injections are synchronized with the respiration, only three injections at room temperature are needed to achieve the desired precision in mechanically ventilated patients.\n\nOnly patients receiving a pulmonary artery catheter according our institution standard procedure of care will be included.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Elective patients for cardiac surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cardiac surgical patients who receive a pulmonary artery catheter according to the institution clinical criteria -\n\nExclusion Criteria:\n\n* Acute cardiac surgery\n* Preoperative arrythmias'}, 'identificationModule': {'nctId': 'NCT00464750', 'briefTitle': 'Study on the Repeatability of Cardiac Output Measurements Dependence of Temperature of Injectate', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'The Impact of Temperature of the Injectate on the Precision (Repeatability) of Cardiac Output Measurements Synchronized With the Respiration (the Temperature Study)', 'orgStudyIdInfo': {'id': '4.2006.1012 / NSD15499'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pulmonary artery catheter', 'type': 'DEVICE', 'otherNames': ['Baxter'], 'description': 'Four series of cardiac output measurements, each series consists of eight measurements using cold and eight measurements using tepid injectate. Randomized order of temperature at first series and crossover design.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olav University Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Idar Kirkeby-Garstad, MD, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Olav University Hospital, Trondheim, Norway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}