Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-26 @ 1:35 PM
Study NCT ID:
NCT05038267
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2021-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Femoral Venous Pulsatility and Right Heart Dysfunction in Heart Surgery: An Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D018497', 'term': 'Ventricular Dysfunction, Right'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-18', 'studyFirstSubmitDate': '2021-08-28', 'studyFirstSubmitQcDate': '2021-09-03', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the prevalence of an elevated pulsatility of the femoral vein on Doppler ultrasound before the induction of general anesthesia', 'timeFrame': 'Before induction of anesthesia to day 1 postoperatively at the intensive care unit', 'description': "An elevated pulsatility on Doppler ultrasound is defined as a biphasic signal of the femoral vein with a retrograde velocity \\> 10 cm/s on a long axis view at an angle correction \\< 60 degrees. If there's signs of cardiac modulation on the Doppler ultrasound, pulsatility index will be measured in long and short axis as followed : (maximal velocity - minimal velocity)/maximal velocity."}], 'secondaryOutcomes': [{'measure': 'Determine the association between an elevated femoral vein pulsatility and diastolic or systolic right ventricular failure, before and after cardiac surgery and at the intensive care unit', 'timeFrame': 'Before induction of anesthesia to day 1 postoperatively at the intensive care unit'}, {'measure': 'Determine the association between an elevated femoral vein pulsatility and the intracardiac pressures of the right heart cavities and the pulmonary artery', 'timeFrame': 'Before induction of anesthesia to day 1 postoperatively at the intensive care unit'}, {'measure': 'Determine the association between the prevalence of an elevated femoral vein pulsatility and the portal vein pulsatility', 'timeFrame': 'Before induction of anesthesia to day 1 postoperatively at the intensive care unit'}, {'measure': 'Determine the impact of positive-pressure ventilation on the femoral vein pulsatility', 'timeFrame': 'After induction of anesthesia and before cardiopulmonary bypass.'}, {'measure': 'Determine the association between a preoperative elevated femoral vein pulsatility and postoperative complications.', 'timeFrame': 'Immediate postoperative to Day 1 postoperatively at the intensive care unit', 'description': 'Postoperative complications will be defined as prolonged mechanical ventilation, inotropes or vasopressors dependencies, surgical second-look, acute kidney injury, mortality, hemorrhage, surgical sites infections, delirium and strokes'}, {'measure': "Compare right and left femoral vein Doppler's ultrasound", 'timeFrame': 'Before induction of anesthesia to day 1 postoperatively at the intensive care unit'}, {'measure': 'Determine the most valid measure between long and short axis ultrasound of the femoral vein, and their respective sensibility and specificity to predict complications', 'timeFrame': 'Before induction of anesthesia to day 1 postoperatively at the intensive care unit'}, {'measure': 'Determine the sensibility and specificity of the values obtained by the femoral vein Doppler ultrasound to predict postoperative complications', 'timeFrame': 'Before induction of anesthesia to day 1 postoperatively at the intensive care unit'}, {'measure': 'Determine if the diameter of the femoral vein as a useful predictor of right heart failure or of post-operative complications', 'timeFrame': 'Before induction of anesthesia to day 1 postoperatively at the intensive care unit'}, {'measure': 'Determine the association between an elevated femoral vein pulsatility and postoperative delirium (as evaluated by the Intensive Care Delirium Screening Checklist)', 'timeFrame': 'Before induction of anesthesia to day 1 postoperatively at the intensive care unit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulsatile Femoral Vein Doppler Flow'], 'conditions': ['Heart; Dysfunction Postoperative, Cardiac Surgery', 'Right Heart Failure', 'Right Ventricular Dysfunction']}, 'referencesModule': {'references': [{'pmid': '40060204', 'type': 'DERIVED', 'citation': 'Hammoud A, Mailhot T, Parent M, Huard K, Lachance O, Tawil P, Calderone A, Levesque S, Jarry S, Beaubien-Souligny W, Couture EJ, Denault AY. Femoral Vein Pulsatility and Neurocognitive Disorder in Cardiac Surgery. CJC Open. 2024 Nov 8;7(2):187-192. doi: 10.1016/j.cjco.2024.11.002. eCollection 2025 Feb.'}, {'pmid': '40032766', 'type': 'DERIVED', 'citation': 'Huard K, Lachance O, Parent M, Tawil P, Saade E, Hammoud A, Couture EJ, Lamarche Y, Jarry S, Calderone A, Robillard P, Levesque S, Beaubien-Souligny W, Denault AY. Prevalence of abnormal common femoral vein pulsatility on Doppler ultrasound in patients undergoing cardiac surgery and its association with adverse events: a prospective cohort study. Can J Anaesth. 2025 Apr;72(4):615-626. doi: 10.1007/s12630-025-02911-9. Epub 2025 Mar 3.'}, {'pmid': '35653255', 'type': 'DERIVED', 'citation': 'Couture EJ, Gronlykke L, Denault AY. New developments in the understanding of right ventricular function in acute care. Curr Opin Crit Care. 2022 Jun 1;28(3):331-339. doi: 10.1097/MCC.0000000000000946.'}]}, 'descriptionModule': {'briefSummary': 'Right heart failure during cardiac surgery is associated with increased perioperative morbidity and mortality. In this context, it is imperative to develop simple diagnostic tools to detect right heart failure. The purpose of this observational study is to determine if ultrasound Doppler of the femoral vein can detect and predict right ventricular failure after cardiac surgeries requiring cardiopulmonary bypass. It is expected that an elevated pulsatility of the femoral vein before the induction of general anesthesia is associated with perioperative right heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults undergoing elective cardiac surgery at the Montreal Heart Institute which requires cardiopulmonary bypass and perioperative trans oesophageal echography', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (at least 18 years old)\n* Able to consent\n* Undergoing elective cardiac surgery at the Montreal Heart Institute\n* Surgery requiring cardiopulmonary bypass\n* Peri-operative trans-oesophageal echography planned\n\nExclusion Criteria:\n\n* Critical preoperative state, defined as vasopressor requirement, mechanical support including intra-aortic balloon, mechanical ventilation or cardiac arrest necessitating resuscitation\n* Know condition that could interfere with femoral venous assessment or interpretation (such as femoral vein thrombosis, femoral instrumentation, ECMO, etc.)\n* Planned cardiac transplantation, implantation of a ventricular assist device or surgery for a congenital condition\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05038267', 'acronym': 'FemousTechno6', 'briefTitle': 'Femoral Venous Pulsatility and Right Heart Dysfunction in Heart Surgery: An Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Montreal Heart Institute'}, 'officialTitle': 'Femoral Venous Pulsatility and Right Heart Dysfunction in Heart Surgery: An Observational Study', 'orgStudyIdInfo': {'id': 'ICM # 2021-2963'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Femous patients', 'description': 'Adults undergoing general anesthesia for an elective cardiac surgery requiring cardiopulmonary bypass'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montreal Heart Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Olivier Lachance, MD', 'class': 'UNKNOWN'}, {'name': 'Melissa Parent, MD', 'class': 'UNKNOWN'}, {'name': 'Patrick Tawil, MD', 'class': 'UNKNOWN'}, {'name': 'Etienne Couture, MD PhD', 'class': 'UNKNOWN'}, {'name': 'William Beaubien Souligny, MD PhD', 'class': 'UNKNOWN'}, {'name': 'Yoan Lamarche, MD PhD', 'class': 'UNKNOWN'}, {'name': 'Alexander Calderone', 'class': 'UNKNOWN'}, {'name': 'Stephanie Jarry, MSc', 'class': 'UNKNOWN'}, {'name': 'Ali Hammoud, RN', 'class': 'UNKNOWN'}, {'name': 'Pierre Robillard, MD', 'class': 'UNKNOWN'}, {'name': 'Olivier Royer, MD', 'class': 'UNKNOWN'}, {'name': 'Elena Saade, MD', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, FRCPC, ABIM-CCM', 'investigatorFullName': 'Andre Denault', 'investigatorAffiliation': 'Montreal Heart Institute'}}}}