Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-01-17 @ 2:29 AM
Study NCT ID:
NCT02382120
Status:
COMPLETED
Last Update Posted:
2018-08-02
First Post:
2015-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of Non-invasive Effective Pulmonary Perfusion Measurement by CO2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-01', 'studyFirstSubmitDate': '2015-03-03', 'studyFirstSubmitQcDate': '2015-03-05', 'lastUpdatePostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy and precision of capnodynamic to measure cardiac output', 'timeFrame': '8 months', 'description': 'Comparison between a reference method (thermodilution) with a new one (capnodynamics)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['carbon dioxide', 'cardiac output', 'ventilation', 'thermodilution'], 'conditions': ['Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '3139547', 'type': 'BACKGROUND', 'citation': 'Capek JM, Roy RJ. Noninvasive measurement of cardiac output using partial CO2 rebreathing. IEEE Trans Biomed Eng. 1988 Sep;35(9):653-61. doi: 10.1109/10.7266. No abstract available.'}, {'pmid': '16809997', 'type': 'RESULT', 'citation': 'Peyton PJ, Venkatesan Y, Hood SG, Junor P, May C. Noninvasive, automated and continuous cardiac output monitoring by pulmonary capnodynamics: breath-by-breath comparison with ultrasonic flow probe. Anesthesiology. 2006 Jul;105(1):72-80. doi: 10.1097/00000542-200607000-00015.'}]}, 'descriptionModule': {'briefSummary': 'Cardiac output monitoring is mandatory in most surgical and critical care patients. Many techniques to assess cardiac output are invasive and/or have many limitations, contraindications and drawbacks. The measurement of cardiac output throughout the CO2 signal is an interesting option due to the simplicity and non-invasive nature of its calculation.\n\nThe present study was designed to compare the cardiac output measurement using a capnodynamic formula versus the reference thermodilution method.', 'detailedDescription': 'This is a prospective and observational study designed to test the accuracy and precision of the non-invasive capnodynamic cardiac output measurement in mechanically ventilated patients. We will study 30 patients undergoing cardiovascular by pass in which an invasive trans-thoracic thermodilution method (PICCOScience) is indicated - the reference method.\n\nA pair of thermodilutions and capnodynamic cardiac output measurement will be performed along the surgery. Analysis of precision will be done at the begining of the protocol and during stable hemodynamic conditions. Accuracy will then assessed using the Bland-Altmann plot and regression analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cardiac surgical ASA II-III patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Programmed cardiac surgeries\n* Surgeries with cardiopulmonary bypass\n\nExclusion Criteria:\n\n* Emergency surgeries.\n* Acute pulmonary diseases\n* Contraindication of femoral catheters.\n* Need of counter-pulsation baloon'}, 'identificationModule': {'nctId': 'NCT02382120', 'briefTitle': 'Accuracy of Non-invasive Effective Pulmonary Perfusion Measurement by CO2', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Privado de Comunidad de Mar del Plata'}, 'officialTitle': 'Accuracy and Precision of Non-invasive Effective Pulmonary Perfusion Measurement Using Volumetric Capnography', 'orgStudyIdInfo': {'id': '23022015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing cardiovascular surgery', 'description': 'Patients ASA 3-4 undergoing cardiac surgery.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '7600', 'city': 'Mar del Plata', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Privado de Comunidad', 'geoPoint': {'lat': -38.00042, 'lon': -57.5562}}], 'overallOfficials': [{'name': 'Gerardo Tusman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Privado de Comunidad de Mar del Plata'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Privado de Comunidad de Mar del Plata', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}