[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659068":3},{"organization":4,"outcomesModule":7,"designInfo":66,"detailedDescription":73,"studyPopulation":65,"armGroups":74,"interventions":86,"overallOfficials":95,"centralContacts":99,"locations":109,"responsibleParty":124,"collaborators":65,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":134,"sex":135,"minAge":136,"maxAge":65,"enrollmentInfo":137,"targetDuration":65,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":148,"overallStatus":153,"whyStopped":65,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"Centre Hospitalier Régional d'Orléans","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":65},[9],{"measure":10,"description":11,"timeFrame":12},"Change in cardiac output during the sixth passive leg raising session compared with the first passive leg raising session, for each day of study procedure","Cardiac output measured every minute using thoracic bioreactance. The study will assess whether the increase in cardiac output during the sixth PLR session is non-inferior to 30% of the increase observed during the first PLR session.","During study procedures on Days 1 and 2 (up to 10 days apart). From enrollment to the end of study (day 2) at 3 months maximum.",[14,18,22,26,30,34,38,42,46,49,53,57,61],{"measure":15,"description":16,"timeFrame":17},"Change in cardiac output response across PLR sessions 1 to 6.","Change in cardiac output measured by thoracic bioreactance during each passive leg raising session. Cardiac output changes observed during sessions 1 through 6 will be described and compared.","During each study day, across six passive leg raising sessions performed over approximately 6 hours. From enrollment to the end of study (day 2) at 3 months maximum.",{"measure":19,"description":20,"timeFrame":21},"Effect of ventilation mode on cardiac output response to passive leg raising","Comparison of the increase in cardiac output induced by passive leg raising between spontaneous breathing sessions and non-invasive ventilation sessions using thoracic bioreactance measurements.","During the two study days (up to 10 days apart). From enrollment to the end of study (day 2) at 3 months maximum.",{"measure":23,"description":24,"timeFrame":25},"Cardiac output evolution during passive leg raising","Minute-by-minute cardiac output measured by thoracic bioreactance during passive leg raising to characterize the temporal profile of the hemodynamic response.","During each 10-minute passive leg raising session. From enrollment to the end of study (day 2) at 3 months maximum",{"measure":27,"description":28,"timeFrame":29},"Effect of ventilation mode on cardiac output evolution during passive leg raising","Comparison of cardiac output trajectories measured during passive leg raising under spontaneous breathing and non-invasive ventilation.","During each 10-minute passive leg raising session on both study days. From enrollment to the end of study (day 2) at 3 months maximum.",{"measure":31,"description":32,"timeFrame":33},"Cardiac output recovery after passive leg raising","Evolution of cardiac output after returning from passive leg raising to the semi-recumbent position, assessed using thoracic bioreactance.","During the 50-minute recovery period following each passive leg raising session. From enrollment to the end of study (day 2) at 3 months maximum.",{"measure":35,"description":36,"timeFrame":37},"LF\u002FHF ratio derived from heart rate variability.","Changes in the low-frequency to high-frequency (LF\u002FHF) ratio derived from heart rate variability analysis as an indicator of autonomic nervous system activity during repeated passive leg raising sessions","During each study day, across six passive leg raising sessions (approximately 6 hours). From enrollment to the end of study (day 2) at 3 months maximum.",{"measure":39,"description":40,"timeFrame":41},"Change in brachial artery diameter measured by ultrasound.","Brachial artery diameter assessed by ultrasound to characterize vasomotor responses associated with passive leg raising.","Measured before, during, and near the end of each passive leg raising session during both study days. From enrollment to the end of study (day 2) at 3 months maximum.",{"measure":43,"description":44,"timeFrame":45},"Agreement between cardiac output measurement methods (bioreactance, Clearsight®, echocardiography).","Comparison of cardiac output measurements obtained by thoracic bioreactance, pulse contour analysis (Clearsight®), and transthoracic echocardiography.","During each study day, across all passive leg raising sessions. From enrollment to the end of study (day 2) at 3 months maximum.",{"measure":47,"description":48,"timeFrame":45},"Agreement between blood pressure measurement methods (oscillometry and Clearsight®).","Comparison of systolic, diastolic, and mean arterial pressure measurements obtained by automated oscillometry and the Clearsight® system",{"measure":50,"description":51,"timeFrame":52},"Correlation between end-tidal carbon dioxide and cardiac output during non-invasive ventilation","Correlation between minute-by-minute end-tidal carbon dioxide values and cardiac output measured by thoracic bioreactance during passive leg raising sessions performed under non-invasive ventilation","During the non-invasive ventilation study day (approximately 6 hours). From enrollment to the end of study (day 2) at 3 months maximum.",{"measure":54,"description":55,"timeFrame":56},"Participant-reported discomfort,.","Participant ratings of discomfort using an 11-point numerical rating scale during study procedures and non-invasive ventilation exposure.","Assessed during and after each passive leg raising session on both study days (approximately 6 hours \u002F study day). From enrollment to the end of study (day 2) at 3 months maximum. Scale from 0 to 10: 0 no discomfort and 10 worst imaginable discomfort.",{"measure":58,"description":59,"timeFrame":60},"Participant-reported respiratory difficulty.","Participant ratings of breathing difficulty using an 11-point numerical rating scale during study procedures and non-invasive ventilation exposure.","Assessed during and after each passive leg raising session on both study days (approximately 6 hours per study day). From enrollment to the end of study (day 2) at 3 months maximum. Scale from 0 to 10: 0 no difficulty and 10 worst imaginable difficulty.",{"measure":62,"description":63,"timeFrame":64},"Participant-reported pain.","Participant ratings of pain using an 11-point numerical rating scale during study procedures and non-invasive ventilation exposure.","Assessed during and after each passive leg raising session on both study days (approximately 6 hours per study day). From enrollment to the end of study (day 2) at 3 months maximum. Scale from 0 to 10: 0 no pain and 10 worst imaginable pain.",null,{"allocation":67,"interventionModel":68,"interventionModelDescription":69,"primaryPurpose":70,"observationalModel":65,"timePerspective":65,"maskingInfo":71},"RANDOMIZED","CROSSOVER","Participants will undergo two study periods in randomized order. During one study day, passive leg raising sessions will be performed during spontaneous breathing. During the other study day, the same sessions will be performed under non-invasive ventilation. A washout period of at least 24 hours and up to 10 days separates study days.","BASIC_SCIENCE",{"masking":72,"maskingDescription":65,"whoMasked":65},"NONE","The passive leg raising maneuver induces a reversible transfer of venous blood from the lower extremities toward the thoracic compartment, thereby increasing cardiac preload. In preload-dependent individuals, PLR increases stroke volume and cardiac output without administration of intravenous fluids.\n\nIn septic shock, repeated fluid challenges remain common during the first days of management but may contribute to positive fluid balance, tissue edema, organ dysfunction, and increased mortality. Since the hemodynamic effects of PLR resemble those of a fluid challenge while avoiding fluid administration, repeated PLR maneuvers could represent an alternative strategy for improving preload and cardiac output.\n\nThe SYSLE-1 study is designed as the first phase of a broader research program aimed at evaluating repeated PLR in septic shock patients. The present study investigates whether the cardiac output response to PLR remains preserved during six repeated PLR sessions in healthy volunteers.\n\nParticipants will complete two study days in randomized order: one under spontaneous breathing and one under non-invasive ventilation. During each study day, six PLR sessions lasting 10 minutes each will be performed and separated by 50-minute recovery periods in a semi-recumbent position.\n\nCardiac output measured by thoracic bioreactance is the primary endpoint. Additional physiological measurements include arterial pressure, heart rate variability, brachial artery diameter, cardiac output measured using pulse contour analysis and echocardiography, end-tidal carbon dioxide, comfort assessments, and safety outcomes.",[75,82],{"label":76,"type":77,"description":78,"interventionNames":79},"Spontaneous Breathing","EXPERIMENTAL","Participants undergo one study day during spontaneous breathing in room air. Each study day consists of six repeated passive leg raising (PLR) sessions performed once every hour over approximately six hours. Before each PLR session, participants remain in a semi-recumbent position (30° trunk elevation) for 5 minutes. They are then moved to a passive leg raising position with the trunk horizontal and legs elevated to 45° for 10 minutes using an electrically operated bed. Following each PLR maneuver, participants return to the semi-recumbent position for 50 minutes before the next PLR session.\n\nThroughout the study day, continuous or repeated measurements of cardiac output, arterial pressure, heart rate, respiratory rate, oxygen saturation, heart rate variability, echocardiographic parameters, and brachial artery diameter are performed according to the study schedule.",[80,81],"Procedure: Passive Leg Raising","Procedure: Non-Invasive Ventilation",{"label":83,"type":77,"description":84,"interventionNames":85},"Non-Invasive Ventilation","Participants undergo one study day during non-invasive ventilation (NIV) delivered through an oronasal mask.\n\nEach study day consists of 6 repeated passive leg raising (PLR) sessions performed once every hour over approximately 6 hours. Before each PLR session, NIV is applied for 5 minutes while the participant remains in a semi-recumbent position (30° trunk elevation). Participants are then moved to a passive leg raising position with the trunk horizontal and legs elevated to 45° for 10 minutes while NIV is maintained. NIV is continued for an additional 5 minutes after return to the semi-recumbent position and is reapplied during the last 5 minutes preceding the next PLR session. This results in repeated 20-minute NIV exposure periods surrounding each PLR maneuver.\n\nContinuous or repeated measurements of cardiac output, arterial pressure, heart rate, respiratory rate, oxygen saturation, end-tidal carbon dioxide, heart (etc.) are performed according to the study schedule.",[80,81],[87,92],{"type":88,"name":89,"description":90,"armGroupLabels":91,"otherNames":65},"PROCEDURE","Passive Leg Raising","Passive leg raising is performed using an electrically operated hospital bed to move participants from a semi-recumbent position (30° trunk elevation) to a position with the trunk horizontal and legs elevated at 45°. Each maneuver lasts 10 minutes and is repeated six times at hourly intervals.",[83,76],{"type":88,"name":83,"description":93,"armGroupLabels":94,"otherNames":65},"Non-invasive ventilation is delivered via an oronasal mask using a critical care ventilator. NIV is applied for 5 minutes before passive leg raising, throughout the 10-minute maneuver, and for 5 minutes after return to the semi-recumbent position, resulting in six repeated 20-minute NIV periods during the study day. Ventilator settings: FiO2 21%, initial PEEP 5 cmH2O (adjustable down to 2 cmH2O for tolerance), and pressure support 0-5 cmH2O, titrated to avoid a tidal volume \\>15 mL\u002Fkg predicted body weight (target 8-12 mL\u002Fkg).",[83,76],[96],{"name":97,"affiliation":5,"role":98},"Mai-Anh PhD NAY, Physician","PRINCIPAL_INVESTIGATOR",[100,105],{"name":97,"role":101,"phone":102,"phoneExt":103,"email":104},"CONTACT","02.38.22.95.57","+33","mai-anh.nay@chu-orleans.fr",{"name":106,"role":101,"phone":107,"phoneExt":103,"email":108},"Fanny LOUAT","0238744295","fanny.louat@chu-orleans.fr",[110],{"facility":5,"status":65,"city":111,"state":112,"zip":113,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":121,"contacts":122},"Orléans","Loiret","45067","France","FR",{"type":117,"coordinates":118},"Point",[119,120],1.90407,47.90248,{"lat":120,"lon":119},[123],{"name":97,"role":101,"phone":102,"phoneExt":103,"email":104},{"type":125,"investigatorFullName":65,"investigatorTitle":65,"investigatorAffiliation":65,"oldNameTitle":65,"oldOrganization":65},"SPONSOR","100659068","effect-of-systematic-and-sequential-leg-elevation-on-cardiac-output-in-healthy-volunteers-100659068",false,"NCT07860515","Effect of Systematic and Sequential Leg Elevation on Cardiac Output in Healthy Volunteers","Effect of Systematic and Sequential Leg Elevation on Cardiac Output in Healthy Volunteers: A Single-Center Prospective Crossover Physiological Study","SYSLE-1","Inclusion Criteria:\n\n* Male or female participant.\n* Age 18 years or older.\n* Healthy volunteer without known acute or chronic disease.\n* No significant cardiovascular or respiratory disease.\n* No medication use within 10 days before the first study day (except oral contraceptives).\n* Intact upper and lower limbs.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Body mass index greater than 35 kg\u002Fm².\n* Use of illicit psychoactive substances within the previous 3 months.\n* Congenital or acquired absence of part or all of an upper or lower limb.\n* Known allergy to hydrocolloid dressings.\n* Pregnant or breastfeeding women.\n* Under guardianship, curatorship, or legal protection.\n* Deprived of liberty.\n* Not affiliated with a health insurance system.\n* Participation in another drug study during an exclusion period.\n* Member of the Lieu de Recherches Interventionnelles sur la Personne Humaine (LRIPH) or Intensive Care Unit staff.\n* Refusal to participate.",true,"ALL","18 Years",{"count":138,"type":139},20,"ESTIMATED","INTERVENTIONAL",[142],"NA","Passive leg raising (PLR) transiently increases venous return and cardiac preload and is commonly used to predict fluid responsiveness in critically ill patients. Repeated fluid boluses contribute to fluid overload in septic shock, whereas PLR may provide similar hemodynamic effects without fluid administration.\n\nBefore evaluating repeated PLR in septic shock patients, it is necessary to determine whether the cardiac output response to PLR remains present during repeated PLR maneuvers.\n\nSYSLE-1 is a prospective interventional physiological crossover study conducted in healthy volunteers. Participants will undergo six consecutive passive leg raising sessions performed either during spontaneous breathing or non-invasive ventilation, in randomized order. The study aims to determine whether the increase in cardiac output induced by the first PLR maneuver persists during repeated PLR sessions.",[145,146,147,89],"Healthy Adult","Cardiac Output","Hemodynamic",[149,150,151,152],"Passive leg raising","Cardiac Ouptut","Thoracic Bioreactance","Noninvasive Ventilation","NOT_YET_RECRUITING","2026-10-06",{"date":156,"type":157},"2026-10-08","ACTUAL",{"date":159,"type":139},"2026-10-10",{"date":161,"type":139},"2029-01-10",{"name":5,"class":6},1]