Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT05741918
Status:
RECRUITING
Last Update Posted:
2024-08-26
First Post:
2023-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiac Output Measurement in Pediatric Intensive Care Unit by Metabolic Monitor (Fick Method) (PEDIA-FICK-ICU)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-23', 'studyFirstSubmitDate': '2023-02-13', 'studyFirstSubmitQcDate': '2023-02-13', 'lastUpdatePostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Intra-class correlation (or concordance) between the measurement of cardiac output (in ml/min) by Fick's method and by echocardiography", 'timeFrame': 'Up to day 3'}], 'secondaryOutcomes': [{'measure': 'Variations of cardiac output before and after Leg Raise Test', 'timeFrame': 'Up to day 3'}, {'measure': 'Adverse events on the day of catheterization', 'timeFrame': 'Up to 21 days', 'description': "Complications possibly due to Fick's method on the day of catheterization : pneumothorax, bleeding, rhythm disorder, gas embolism, failure to place, other"}, {'measure': 'Adverse events on the day of catheter removal', 'timeFrame': 'Up to 21 days', 'description': "Complications possibly due to Fick's method on the day of catheter removal : catheter thrombosis, catheter infection, non-functional oximetry catheter"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac output', 'Oxygen Consumption (VO2)', 'Fick', 'Pediatric Intensive Care Unit'], 'conditions': ['Intensive Care Units, Pediatric']}, 'descriptionModule': {'briefSummary': "Cardiac output measurement is one of the most frequently used haemodynamic parameter used for intensive care unit (ICU) patients. In pediatric ICU, it is often measured with echocardiography that is a non-invasive method but is operator dependant and can't provide continuous monitoring.\n\nThe goal of this clinical trial is to evaluate the feasibility of cardiac output measurement by Fick's method, non-invasive and allowing continuous monitoring, in comparison to echocardiography in pediatric intensive care unit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '28 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient under 18 years old\n* Patient over 10 kg\n* Patient requiring intubation or intubated with a cuffed tube\n* Patient requiring a central venous line in superior vena cava territory\n\nExclusion Criteria:\n\n* Mechanical ventilation with leak\n* Bad echogenicity preventing echocardiography\n* Absence of written informed consent\n* Patient not affiliated to French Health Insurance or not covered by public health insurance\n* Patient with a legal protection'}, 'identificationModule': {'nctId': 'NCT05741918', 'acronym': 'PEDIA-FICK-ICU', 'briefTitle': 'Cardiac Output Measurement in Pediatric Intensive Care Unit by Metabolic Monitor (Fick Method) (PEDIA-FICK-ICU)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Cardiac Output Measurement in Pediatric Intensive Care Unit by Metabolic Monitor (Fick Method) : Prospective Feasibility Study', 'orgStudyIdInfo': {'id': 'RECHMPL22_0227'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pediatric Intensive Care Units Patients', 'description': 'Patients under 18 admitted in pediatric intensive care unit', 'interventionNames': ["Diagnostic Test: Fick's method", 'Diagnostic Test: Echocardiography']}], 'interventions': [{'name': "Fick's method", 'type': 'DIAGNOSTIC_TEST', 'description': 'Cardiac output measurement by Fick method', 'armGroupLabels': ['Pediatric Intensive Care Units Patients']}, {'name': 'Echocardiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cardiac output measurement by echocardiography', 'armGroupLabels': ['Pediatric Intensive Care Units Patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Arthur GAVOTTO, MD', 'role': 'CONTACT'}], 'facility': 'UH Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'Arthur GAVOTTO, PH-U', 'role': 'CONTACT', 'email': 'a-gavotto@chu-montpellier.fr', 'phone': '+334.67.33.66.09'}, {'name': 'Gilles CAMBONIE, Pr', 'role': 'CONTACT', 'email': 'g-cambonie@chu-montpellier.fr', 'phone': '+334.67.33.65.56'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}