Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-29 @ 1:35 AM
Study NCT ID:
NCT06822361
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-12
First Post:
2024-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Uncalibrated Pulse Contour to Assess Fluid Responsiveness in Off Pump Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2024-12-18', 'studyFirstSubmitQcDate': '2025-02-06', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response to vascular filling', 'timeFrame': 'From enrollment to completion of chirurgy (24 hours)', 'description': 'an increase of more than 10% (compared with basal value) in the sub-aortic VTI value measured in TEE after filling (gold standard).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vascular filling', 'systolic ejection volume', 'uncalibrated pulse-wave contour analysis'], 'conditions': ['Coronary Surgery']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to Compare the performance of uncalibrated pulse wave contour analysis compared with transesophageal echocardiography (TEE) to assess response to a vascular filling test during beating-heart coronary artery bypass surgery, in people over age of 18; hospitalized for scheduled beating heart bypass surgery The aim question is to evaluate the ability of a less invasive cardiac output monitor (uncalibrated pulse wave contour analysis) compared with a reference cardiac output measurement (transesophageal echocardiography) to enable optimization of vascular filling by good assessment of the response to vascular filling in a high-risk perioperative patient population.\n\nAs part of hemodynamic monitoring, every patient undergoing beating-heart coronary bypass surgery is fitted with a radial arterial catheter immediately after induction of anesthesia, enabling continuous measurement of blood pressure. Hemodynamic optimization in these patients also involves fitting a transesophageal ultrasound probe to optimize cardiac output using the various therapies available (vascular filling, vasopressors, inotropes).\n\nA specific sensor (FloTrac°, Hemosphere, Edwards°) will be connected to the arterial pressure line to obtain a systolic ejection volume value by analyzing the contour of the uncalibrated pulse wave.\n\nThe hemodynamic management of the patient, and the decision to perform a vascular filling test, will be left to the discretion of the practitioner in charge of the patient in the operating room.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient admitted to the cardiac surgery department for surgery under extracorporeal circulation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatient :\n\n* 18 years of age and older\n* Hospitalized for scheduled beating-heart coronary bypass surgery\n* Beneficiary of a social security plan\n* Not opposed to participating\n\nExclusion Criteria:\n\n* Patients undergoing surgery with extracorporeal circulation\n* Patients with a history of surgery or intra-esophageal pathology contraindicating TEE\n* Patient refusing to participate in the study\n* Unavailability of TEE or uncalibrated pulse-wave contour device\n* Minors\n* Protected adults, adults unable to give consent and not under protective supervision\n* Persons deprived of liberty, hospitalized without consent\n* Pregnant women, parturients and nursing mothers\n* Patients not affiliated to the social security system\n* Emergency situations'}, 'identificationModule': {'nctId': 'NCT06822361', 'acronym': 'UPC-OPCS', 'briefTitle': 'Uncalibrated Pulse Contour to Assess Fluid Responsiveness in Off Pump Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': 'Assessment of Response to Vascular Filling by Uncalibrated Pulse Wave Contour Analysis in Beating Heart Cardiac Surgery', 'orgStudyIdInfo': {'id': '2024/CHU/57'}, 'secondaryIdInfos': [{'id': '2024-A02390-47', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Arthur Neuschwander, Doctor', 'role': 'CONTACT', 'email': 'arthur.neuschwander@chu-reunion.fr', 'phone': '+262 262905050'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}