Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-01 @ 3:07 AM
Study NCT ID:
NCT04310904
Status:
UNKNOWN
Last Update Posted:
2023-05-10
First Post:
2020-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Output Assessment by Using Saline Contrast Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-09', 'studyFirstSubmitDate': '2020-03-13', 'studyFirstSubmitQcDate': '2020-03-13', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'variation of cardiac output assessment (CO)', 'timeFrame': 'day 0', 'description': 'correlation will be done between contrast and the reference method cardiac Doppler method.'}], 'secondaryOutcomes': [{'measure': 'variation of cardiac output assessment (CO) in patients with a swan gaz catheter', 'timeFrame': 'day 0', 'description': 'comparison will be performed between the contrast CO and the thermodilution CO in the group of patients with a swan ganz catheter'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['echocardiography', 'Doppler cardiac output', 'contrast', 'thermodilution', 'agitated saline', 'ICU'], 'conditions': ['Echocardiography']}, 'descriptionModule': {'briefSummary': 'Cardiac output (CO) assessment is one of the cornerstone of hemodynamic evaluation in ICU patients. CO is usually measured using invasive methods or non-invasive methods. Thermodilution is considered as the gold standard for CO assessment. Cardiac Doppler as well demonstrated to be accurate but needs manipulations and good knowledge and skills. The investigators developed a new technique using injection of agitated saline solution to evaluate CO without any manual measurement and then observer independent.', 'detailedDescription': 'The investigators decided to conduct a prospective observational study to compare contrast assessment of CO and cardiac Doppler technique. Patients hospitalized in ICU will be included if they need a trans esophageal echocardiographic evaluation and a research of intra cardiac shunt (using a saline contrast test). Patients with Swan Ganz catheter will be included as well. Cardiac output will be measured using cardiac Doppler. Simultaneously, 4.5 ml of saline with 0.5 ml of air will be agitated to have a contrast solution. This solution will be injected as usual and echocardiographic imaging will be recorded. These imaging will be analyzed off-line and CO will be calculated with an algorithm previously developed and compared with the reference method. In case of swan ganz catheter, the cardiac output will be also measured using the thermodilution technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all ICU patients intubated/ventilated with a central line and an arterial catheter who need trans esophageal echocardiography examination with a saline contrast test.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all ICU patients intubated/ventilated with a central line and an arterial catheter who need trans esophageal echocardiography examination with a saline contrast test.\n\nExclusion Criteria:\n\n* patients under 18 years old\n* pregnant patients\n* moribund patients'}, 'identificationModule': {'nctId': 'NCT04310904', 'acronym': 'CardioLog', 'briefTitle': 'Cardiac Output Assessment by Using Saline Contrast Injection', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Cardiac Output Assessment by Using Saline Contrast Injection', 'orgStudyIdInfo': {'id': 'PI2018_843_0057'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ICU cardiac output (CO) assessment patients', 'description': 'all ICU patients intubated/ventilated with a central line and an arterial catheter who need trans esophageal echocardiography examination with a saline contrast test.', 'interventionNames': ['Other: contrast assessment of cardiac output (CO)', 'Other: cardiac Doppler technique']}], 'interventions': [{'name': 'contrast assessment of cardiac output (CO)', 'type': 'OTHER', 'description': 'Patients hospitalized in ICU will be included if they need a trans esophageal echocardiographic evaluation and a research of intra cardiac shunt (using a saline contrast test). Patients with Swan Ganz catheter will be included as well. Cardiac output will be measured using cardiac Doppler. Simultaneously, 4.5 ml of saline with 0.5 ml of air will be agitated to have a contrast solution. This solution will be injected as usual and echocardiographic imaging will be recorded. These imaging will be analyzed off-line and CO will be calculated with an algorithm previously developed and compared with the reference method. In case of swan ganz catheter, the cardiac output will be also measured using the thermodilution technique.', 'armGroupLabels': ['ICU cardiac output (CO) assessment patients']}, {'name': 'cardiac Doppler technique', 'type': 'OTHER', 'description': 'Patients hospitalized in ICU will be included if they need a trans esophageal echocardiographic evaluation and a research of intra cardiac shunt (using a saline contrast test). Patients with Swan Ganz catheter will be included as well. Cardiac output will be measured using cardiac Doppler. Simultaneously, 4.5 ml of saline with 0.5 ml of air will be agitated to have a contrast solution. This solution will be injected as usual and echocardiographic imaging will be recorded. These imaging will be analyzed off-line and CO will be calculated with an algorithm previously developed and compared with the reference method. In case of swan ganz catheter, the cardiac output will be also measured using the thermodilution technique.', 'armGroupLabels': ['ICU cardiac output (CO) assessment patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80480', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Michel Slama, Pr', 'role': 'CONTACT', 'phone': '(33)3 22 08 78 41'}, {'name': 'Julien Maizel, Pr', 'role': 'CONTACT', 'email': 'maizel.julien@chu-amiens.fr', 'phone': '(33)3 22 08 78 07'}], 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Michel Slama, Pr', 'role': 'CONTACT', 'email': 'slama.michel@chu-amiens.fr', 'phone': '(33)3 22 08 78 41'}, {'name': 'Julien Maizel, Pr', 'role': 'CONTACT', 'email': 'maizel.julien@chu-amiens.fr', 'phone': '(33)3 22 08 78 07'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}