Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-01-24 @ 7:14 PM
Study NCT ID:
NCT03394768
Status:
TERMINATED
Last Update Posted:
2021-05-11
First Post:
2018-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison Between NICOM-Cheetah and Flotrac-Vigileo for Cardiac Output Monitoring.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'serene_yeow@cgh.com.sg', 'phone': '+6581258267', 'title': 'Serene Yeow, Senior Executive, Clinical Trials and Research Unit', 'phoneExt': '+656426781', 'organization': 'Changi General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 years', 'description': 'All-Cause Mortality, Serious, or Other (non-serious) Adverse Events were monitored/assessed, but none observed.', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'Patients will be treated as per department protocols and no additional intervention will be performed. Each patient will have an arterial catheter inserted as per our usual practice. All patients will have the FloTrac® connected to the arterial catheter (standard of care in CGH SICU) and the NICOM Cheetah® electrodes placed on the skin across the anterior thoracic wall. The NICOM CO monitor involves the application of non-invasive sensor strips. In this study, it will be applied to patients receiving the FloTrac (standard of care), on top of the standard care of monitoring with Flotrac.\n\nNo additional intervention: Patients will be treated as per department protocols and no additional intervention will be performed', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Degree of Disagreement, %', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Patients will be treated as per department protocols and no additional intervention will be performed. Each patient will have an arterial catheter inserted as per our usual practice. All patients will have the FloTrac® connected to the arterial catheter (standard of care in CGH SICU) and the NICOM Cheetah® electrodes placed on the skin across the anterior thoracic wall. The NICOM CO monitor involves the application of non-invasive sensor strips. In this study, it will be applied to patients receiving the FloTrac (standard of care), on top of the standard care of monitoring with Flotrac.\n\nNo additional intervention: Patients will be treated as per department protocols and no additional intervention will be performed'}], 'classes': [{'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 hours of data collected for each participant', 'description': 'Comparison of cardiac output monitoring capabilities of the NICOM Cheetah® versus the FloTrac®. Cardiac output defined as the amount of blood the heart pumps through the circulatory system in a minute. Bland-Altman analysis used to compare the level of disagreement between the 2 devices, %.', 'unitOfMeasure': 'percentage of disagreement', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'Patients will be treated as per department protocols and no additional intervention will be performed. Each patient will have an arterial catheter inserted as per our usual practice. All patients will have the FloTrac® connected to the arterial catheter (standard of care in CGH SICU) and the NICOM Cheetah® electrodes placed on the skin across the anterior thoracic wall. The NICOM CO monitor involves the application of non-invasive sensor strips. In this study, it will be applied to patients receiving the FloTrac (standard of care), on top of the standard care of monitoring with Flotrac.\n\nNo additional intervention: Patients will be treated as per department protocols and no additional intervention will be performed'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants recruited from the surgical intensive care unit of Changi General Hospital, Singapore, from 2018 until 2021'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Patients will be treated as per department protocols and no additional intervention will be performed. Each patient will have an arterial catheter inserted as per our usual practice. All patients will have the FloTrac® connected to the arterial catheter (standard of care in CGH SICU) and the NICOM Cheetah® electrodes placed on the skin across the anterior thoracic wall. The NICOM CO monitor involves the application of non-invasive sensor strips. In this study, it will be applied to patients receiving the FloTrac (standard of care), on top of the standard care of monitoring with Flotrac.\n\nNo additional intervention: Patients will be treated as per department protocols and no additional intervention will be performed'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.58', 'spread': '12.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Singapore', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-24', 'size': 255488, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-07-15T23:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Interim analysis shown futility to continue due to lack of benefit.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-10', 'studyFirstSubmitDate': '2018-01-03', 'resultsFirstSubmitDate': '2021-01-26', 'studyFirstSubmitQcDate': '2018-01-08', 'lastUpdatePostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-11', 'studyFirstPostDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of Disagreement, %', 'timeFrame': '10 hours of data collected for each participant', 'description': 'Comparison of cardiac output monitoring capabilities of the NICOM Cheetah® versus the FloTrac®. Cardiac output defined as the amount of blood the heart pumps through the circulatory system in a minute. Bland-Altman analysis used to compare the level of disagreement between the 2 devices, %.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Output, Low']}, 'referencesModule': {'references': [{'pmid': '17458538', 'type': 'BACKGROUND', 'citation': 'Squara P, Denjean D, Estagnasie P, Brusset A, Dib JC, Dubois C. Noninvasive cardiac output monitoring (NICOM): a clinical validation. Intensive Care Med. 2007 Jul;33(7):1191-1194. doi: 10.1007/s00134-007-0640-0. Epub 2007 Apr 26.'}, {'pmid': '18340540', 'type': 'BACKGROUND', 'citation': 'Raval NY, Squara P, Cleman M, Yalamanchili K, Winklmaier M, Burkhoff D. Multicenter evaluation of noninvasive cardiac output measurement by bioreactance technique. J Clin Monit Comput. 2008 Apr;22(2):113-9. doi: 10.1007/s10877-008-9112-5. Epub 2008 Mar 14.'}, {'pmid': '19454009', 'type': 'BACKGROUND', 'citation': 'Marque S, Cariou A, Chiche JD, Squara P. Comparison between Flotrac-Vigileo and Bioreactance, a totally noninvasive method for cardiac output monitoring. Crit Care. 2009;13(3):R73. doi: 10.1186/cc7884. Epub 2009 May 19.'}, {'pmid': '25276302', 'type': 'BACKGROUND', 'citation': 'Mehta Y, Arora D. Newer methods of cardiac output monitoring. World J Cardiol. 2014 Sep 26;6(9):1022-9. doi: 10.4330/wjc.v6.i9.1022.'}]}, 'descriptionModule': {'briefSummary': 'Cardiac output (CO) monitoring is an important tool in critically ill patients with haemodynamic instability. Traditionally, this has been accomplished using the pulmonary artery catheter (PAC). However, its use has been associated with various complications such as pneumothorax, arrhythmia, infection, pulmonary valve injury and embolism. This has led to the development of various minimally invasive cardiac output monitoring devices such as the oesophageal Doppler, PiCCO®, NiCCO® and FloTrac®. These devices however have their inherent limitations and though minimally invasive, are still not without risks to the patient. More recently a completely non-invasive CO monitoring device, NICOM Cheetah® has been introduced. Its use is based on thoracic bioreactance and it involves placement of 4 electrodes on either side of the thorax and it analyses changes in the phase of electrical voltage signal to the current applied across the thorax. Initial validation studies on the NICOM Cheetah® device revealed promising results. This study intends to compare cardiac output monitoring capabilities of the NICOM Cheetah® device using the FloTrac® CO monitor as a reference.', 'detailedDescription': 'This will be a single centre prospective observational study. 50 consecutive patients admitted to the surgical intensive care unit (SICU) who are deemed to require cardiac output monitoring by the treating intensivist will be studied. Data collection is planned to be carried out over 2 consecutive years. Inclusion criteria are: 1) Patients who are deemed to require cardiac output monitoring. 2) Patients 21 years old and above. 3) American Society of Anesthesiologist (ASA) physical status 1 to 4. Exclusion criteria are: 1) Patients who are not on mechanical ventilation. 2) Patients who are not in sinus rhythm. 3) Patients with allergy to adhesive tapes. Patients will be treated as per department protocols and no additional intervention will be performed. Each patient will have an arterial catheter inserted as per our usual practice. All patients will have the FloTrac® connected to the arterial catheter (standard of care in CGH SICU) and the NICOM Cheetah® electrodes placed on the skin across the anterior thoracic wall. The FloTrac CO monitor is the current standard of care for cardiac output monitoring in the SICU of CGH. All patients deemed to require cardiac output monitoring will receive the FloTrac (as per departmental practice). The NICOM CO monitor involves the application of non-invasive sensor strips. In this study, it will be applied to patients receiving the FloTrac (standard of care), on top of the standard care of monitoring with Flotrac. For each patient, standard demographic and SICU data (age, gender, comorbidities, ASA score, admission diagnosis, type of surgery, cause of haemodynamic instability, mean arterial pressure (MAP) and central venous pressure (CVP) at the time of instituting cardiac output (CO) monitoring, use of inotropic support, presence of renal replacement therapy, presence of mechanical ventilation and APACHE II score) will be collected. Cardiac Index (CI) values simultaneously recorded by the NICOM Cheetah® and FloTrac® on a 15-minutely basis for the first 10-hour period will also be collected. These data will be automatically recorded by the FloTrac® Vigilance monitor and the Cheetah NICOM monitor and transcribed to a data entering/analysis software by the principal and co-principal investigators for data analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the surgical intensive care unit (SICU) who are deemed to require cardiac output monitoring by the treating intensivist', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are deemed to require cardiac output monitoring.\n* Patients 21 years old and above\n* American Society of Anesthesiologist (ASA) physical status 1 to 4\n\nExclusion Criteria:\n\n* Patients who are not on mechanical ventilation.\n* Patients who are not in sinus rhythm.\n* Patients with allergy to adhesive tapes'}, 'identificationModule': {'nctId': 'NCT03394768', 'briefTitle': 'Comparison Between NICOM-Cheetah and Flotrac-Vigileo for Cardiac Output Monitoring.', 'organization': {'class': 'OTHER', 'fullName': 'Changi General Hospital'}, 'officialTitle': 'An Observational Study Comparing NICOM-Cheetah Versus Flotrac-Vigileo for Cardiac Output Monitoring in the Surgical Intensive Care Unit.', 'orgStudyIdInfo': {'id': '2017/2820'}, 'secondaryIdInfos': [{'id': 'CHF2017.08-S', 'type': 'OTHER_GRANT', 'domain': 'CGH Research Grant 2017'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'NICOM Cheetah®', 'description': 'Patients will be treated as per department protocols and no additional intervention will be performed. Each patient will have an arterial catheter inserted as per our usual practice. All patients will have the FloTrac® connected to the arterial catheter (standard of care in CGH SICU) and the NICOM Cheetah® electrodes placed on the skin across the anterior thoracic wall. The NICOM CO monitor involves the application of non-invasive sensor strips. In this study, it will be applied to patients receiving the FloTrac (standard of care), on top of the standard care of monitoring with Flotrac.', 'interventionNames': ['Other: No additional intervention']}, {'label': 'FloTrac®', 'description': 'Same patient population as the NICOM Cheetah® group as described above as all patients will have the FloTrac® connected to the arterial catheter (standard of care in CGH SICU) and the NICOM Cheetah® electrodes placed on the skin across the anterior thoracic wall. The FloTrac CO monitor is the current standard of care for cardiac output monitoring in the SICU of CGH. All patients deemed to require cardiac output monitoring will receive the FloTrac (as per departmental practice).', 'interventionNames': ['Other: No additional intervention']}], 'interventions': [{'name': 'No additional intervention', 'type': 'OTHER', 'description': 'Patients will be treated as per department protocols and no additional intervention will be performed', 'armGroupLabels': ['FloTrac®', 'NICOM Cheetah®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '529889', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Surgical Intensive Care Unit, Changi General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'See Seong Chang, MBBS, MMed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changi General Hospital'}, {'name': 'Louis Ng, MBBS, ANZCA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changi General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be available to anyone else other than the investigators of this study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Chang See Seong', 'investigatorAffiliation': 'Changi General Hospital'}}}}