Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT03937102
Status:
COMPLETED
Last Update Posted:
2023-03-22
First Post:
2019-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Measurement of Cardiac Output in Intensive Care Unit With Unstable Hemodynamic: Validation of Physioflow® Device Versus Trans Thoracic Echocardiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-21', 'studyFirstSubmitDate': '2019-04-25', 'studyFirstSubmitQcDate': '2019-05-02', 'lastUpdatePostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of cardiac output with transthoracic echocardiography (TTE) before PLR', 'timeFrame': 'during one hour , the day of inclusion', 'description': 'Measure of Cardiac output with transthoracic echocardiography (TTE) before passive leg raising maneuver (PLR)'}, {'measure': 'Measure of Cardiac output with Physioflow before PLR', 'timeFrame': 'during one hour , the day of inclusion', 'description': 'Measure of Cardiac output with Physioflow before passive leg raising maneuver (PLR)'}, {'measure': 'Measure of cardiac output with transthoracic echocardiography (TTE) after PLR', 'timeFrame': 'during one hour , the day of inclusion', 'description': 'Measure of cardiac output with transthoracic echocardiography (TTE) after passive leg raising maneuver (PLR)'}, {'measure': 'Measure of cardiac output with Physioflow after PLR', 'timeFrame': 'during one hour , the day of inclusion', 'description': 'Measure of cardiac output with Physioflow after passive leg raising maneuver (PLR)'}], 'secondaryOutcomes': [{'measure': 'Measure of cardiac output with transthoracic echocardiography (TTE) after volume expansion', 'timeFrame': 'during one hour , the day of inclusion', 'description': 'Measure of cardiac output with transthoracic echocardiography (TTE) after volume expansion'}, {'measure': 'Measure of cardiac output with Physioflow after volume expansion', 'timeFrame': 'during one hour , the day of inclusion', 'description': 'Measure of cardiac output with Physioflow after volume expansion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiac output', 'trans thoracic echocardiography', 'passive leg raising', 'volume expansion'], 'conditions': ['Cardiac Output']}, 'descriptionModule': {'briefSummary': 'Physioflow® is a new device for measuring cardiac output in a non-invasive way using a thoracic bioimpedance technique. This technique has been validated in patients in stress tests as well as in Chronic Obstructive Pulmonary Disease (COPD) patients, in obese patients and in children. Very little work has been published in intensive care unit (ICU) and no studies have been done on hemodynamically unstable patients. The aim of this work is to compare the cardiac output measured by Physioflow® to the transthoracic echocardiography (TTE) in ventilated, sedated patients hospitalized in ICU receiving catecholamines and for whom the attending physician wants to evaluate the fluid responsiveness using the TTE and a passive leg raising maneuver (PLR).', 'detailedDescription': 'All patients included will be simultaneously monitored with TTE and the Physioflow® thoracic electrical bioimpedance device. Cardiac output is measured by the Physioflow® Thoracic Bioimpedance Device and TTE before and after PLR. If the attending physician decide to administer fluid expansion a new set of cardiac output measurement will be performed before and after the volume expansion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient ≥18 year-old, sedated and adapted to the assisted controlled ventilation, receiving catecholamine (norepinephrine, epinephrine or dobutamine), requiring an haemodynamic evaluation by trans-thoracic echocardiography and PLR according to the attending physician.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient more than 18 year-old\n* patient sedated and adapted to the assisted controlled ventilation\n* patient receiving catecholamine (norepinephrine, epinephrine or dobutamine)\n* patient requiring an haemodynamic evaluation by trans-thoracic echocardiography and PLR according to the attending physician\n\nExclusion Criteria:\n\n* pregnant women\n* patients with a poor echogenicity\n* patients deprived of public law'}, 'identificationModule': {'nctId': 'NCT03937102', 'acronym': 'Reacshock', 'briefTitle': 'Measurement of Cardiac Output in Intensive Care Unit With Unstable Hemodynamic: Validation of Physioflow® Device Versus Trans Thoracic Echocardiography', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Measurement of Cardiac Output in Intensive Care Unit With Unstable Hemodynamic: Validation of Physioflow® Device Versus Trans Thoracic Echocardiography', 'orgStudyIdInfo': {'id': 'PI2018_843_0001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'cardiac output measure with TTE', 'type': 'PROCEDURE', 'description': 'All patients included will be simultaneously monitored with transthoracic echocardiography (TTE) and the Physioflow® thoracic electrical bioimpedance device. Cardiac output is measured by the Physioflow® Thoracic Bioimpedance Device and TTE before and after passive leg raising maneuver (PLR)'}, {'name': 'cardiac output measure with Physioflow® thoracic electrical bioimpedance', 'type': 'PROCEDURE', 'description': 'All patients included will be simultaneously monitored with transthoracic echocardiography (TTE) and the Physioflow® thoracic electrical bioimpedance device. Cardiac output is measured by the Physioflow® Thoracic Bioimpedance Device and TTE before and after passive leg raising maneuver (PLR)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80480', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'overallOfficials': [{'name': 'Didier Thevenin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier de Lens'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier de Lens', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}