Ignite Creation Date:
2025-12-17 @ 1:43 PM
Ignite Modification Date:
2025-12-23 @ 4:53 PM
Study NCT ID:
NCT02070861
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2014-02-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-invasive Evaluation of Volume Status Using Exhaled Carbon Dioxide and Pulse Contour Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-14', 'studyFirstSubmitDate': '2014-02-23', 'studyFirstSubmitQcDate': '2014-02-24', 'lastUpdatePostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in cardiac output', 'timeFrame': '5 Minutes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac output', 'Exhaled CO2', 'Nexfin', 'Esophageal Doppler'], 'conditions': ['Changes in Cardiac Output']}, 'referencesModule': {'references': [{'pmid': '31281675', 'type': 'DERIVED', 'citation': 'Hoff IE, Hoiseth LO, Kirkeboen KA, Landsverk SA. Volumetric and End-Tidal Capnography for the Detection of Cardiac Output Changes in Mechanically Ventilated Patients Early after Open Heart Surgery. Crit Care Res Pract. 2019 May 30;2019:6393649. doi: 10.1155/2019/6393649. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': "The investigators hypothesize that changes in blood circulation can be reflected by exhaled CO2 provided CO2-production in the tissues and ventilation from the lungs are stable. The investigators want to explore changes in cardiac output (the amount of blood being pumped out of the heart each minute) in patients using different devices: an esophagus ultrasound device measuring cardiac output, a finger cuff measuring blood pressure and cardiac output, and exhaled carbondioxide in the patients' breath measured by the ventilator.\n\nThe investigators investigate patients after bypass surgery or heart valve replacement, and induce changes in cardiac output with passive leg raise or ventricular pacing.", 'detailedDescription': 'Measurements with the finger cuff (pulse contour analyses) were aborted due to technical difficulties.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persons 18 years or older scheduled to undergo arteriocoranary bypass surgery or aortic valve replacement.\n\nExclusion Criteria:\n\n* Esophageal pathology, EF \\<40%'}, 'identificationModule': {'nctId': 'NCT02070861', 'briefTitle': 'Non-invasive Evaluation of Volume Status Using Exhaled Carbon Dioxide and Pulse Contour Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Non-invasive Volume Evaluation With Exhaled Carbon Dioxide and Pulse Contour Analysis (Nexfin)', 'orgStudyIdInfo': {'id': '2013/1605'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Comparing cardiac output changes', 'description': 'Explore the relationship between changes in cardiac output measured with eosophagal Doppler, the volume-clamp-method and exhaled CO2 during ventricular pacing and passive leg raise.\n\nMeasurements with the volume-clamp-method were aborted due to technological difficulties.', 'interventionNames': ['Other: Ventricular pacing and passive leg raise']}], 'interventions': [{'name': 'Ventricular pacing and passive leg raise', 'type': 'OTHER', 'description': 'Ventricular pacing and passive leg raise', 'armGroupLabels': ['Comparing cardiac output changes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0454', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital, Ullevål', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Leiv Arne Rosseland, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Oslo University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share individual participant data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Norwegian Air Ambulance Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ingrid Elise Hoff', 'investigatorAffiliation': 'Oslo University Hospital'}}}}