Healthy AdultSYSLE-1NCT07860515
Effect of Systematic and Sequential Leg Elevation on Cardiac Output in Healthy Volunteers
A study testing Passive Leg Raising and Non-Invasive Ventilation in people with Healthy Adult and Cardiac Output, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult, Cardiac Output, Hemodynamic
- What is being tested?
- Passive Leg Raising and Non-Invasive Ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2026to 10 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female participant.
- Age 18 years or older.
- Healthy volunteer without known acute or chronic disease.
- No significant cardiovascular or respiratory disease.
- No medication use within 10 days before the first study day (except oral contraceptives).
- Intact upper and lower limbs.
- Written informed consent.
Who cannot join
- Body mass index greater than 35 kg/m².
- Use of illicit psychoactive substances within the previous 3 months.
- Congenital or acquired absence of part or all of an upper or lower limb.
- Known allergy to hydrocolloid dressings.
- Pregnant or breastfeeding women.
- Under guardianship, curatorship, or legal protection.
Show all 11Show fewer
- Deprived of liberty.
- Not affiliated with a health insurance system.
- Participation in another drug study during an exclusion period.
- Member of the Lieu de Recherches Interventionnelles sur la Personne Humaine (LRIPH) or Intensive Care Unit staff.
- Refusal to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre Hospitalier Régional d'Orléans
Orléans, Loiret, 45067
Mai-Anh PhD NAY, Physician, 02.38.22.95.57 ext. +33, mai-anh.nay@chu-orleans.fr
About this study
Official title: Effect of Systematic and Sequential Leg Elevation on Cardiac Output in Healthy Volunteers: A Single-Center Prospective Crossover Physiological Study
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.
Before 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.
SYSLE-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.
Read the detailed description
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.
In 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.
The 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.
Participants 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.
Cardiac 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.
- Conditions
- Healthy Adult, Cardiac Output, Hemodynamic, Passive Leg Raising
- Being tested
- Passive Leg Raising, Non-Invasive Ventilation
- Keywords
- Passive leg raising, Cardiac Ouptut, Thoracic Bioreactance, Noninvasive Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive Leg RaisingProcedure or surgery
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.
Non-Invasive VentilationProcedure or surgery
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/kg predicted body weight (target 8-12 mL/kg).
| Study group | Role | What they receive |
|---|---|---|
| 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.
Throughout 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. Receives: Procedure: Passive Leg Raising; Procedure: Non-Invasive Ventilation |
| Non-Invasive Ventilation | Experimental | Participants undergo one study day during non-invasive ventilation (NIV) delivered through an oronasal mask.
Each 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.
Continuous 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. Receives: Procedure: Passive Leg Raising; Procedure: Non-Invasive Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (13)
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.
Measured: 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.
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.
Measured: During the two study days (up to 10 days apart). From enrollment to the end of study (day 2) at 3 months maximum.
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.
Measured: During each 10-minute passive leg raising session. From enrollment to the end of study (day 2) at 3 months maximum
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.
Measured: 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.
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.
Measured: 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.
LF/HF ratio derived from heart rate variability.
Changes in the low-frequency to high-frequency (LF/HF) ratio derived from heart rate variability analysis as an indicator of autonomic nervous system activity during repeated passive leg raising sessions
Measured: 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.
Change in brachial artery diameter measured by ultrasound.
Brachial artery diameter assessed by ultrasound to characterize vasomotor responses associated with passive leg raising.
Measured: 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.
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.
Measured: During each study day, across all passive leg raising sessions. From enrollment to the end of study (day 2) at 3 months maximum.
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
Measured: During each study day, across all passive leg raising sessions. From enrollment to the end of study (day 2) at 3 months maximum.
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
Measured: During the non-invasive ventilation study day (approximately 6 hours). From enrollment to the end of study (day 2) at 3 months maximum.
Participant-reported discomfort,.
Participant ratings of discomfort using an 11-point numerical rating scale during study procedures and non-invasive ventilation exposure.
Measured: Assessed during and after each passive leg raising session on both study days (approximately 6 hours / 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.
Participant-reported respiratory difficulty.
Participant ratings of breathing difficulty using an 11-point numerical rating scale during study procedures and non-invasive ventilation exposure.
Measured: 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.
Participant-reported pain.
Participant ratings of pain using an 11-point numerical rating scale during study procedures and non-invasive ventilation exposure.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start10 Oct 2026 (estimated)
- Primary completion10 Jan 2029 (estimated)
- Study completion10 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mai-Anh PhD NAY, Physician, Principal investigator, Centre Hospitalier Régional d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860515
- Sponsor's protocol ID
- CHUO-2025-20
- Acronym
- SYSLE-1
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cavallaro F, Sandroni C, Marano C, La Torre G, Mannocci A, De Waure C, Bello G, Maviglia R, Antonelli M. Diagnostic accuracy of passive leg raising for prediction of fluid responsiveness in adults: systematic review and meta-analysis of clinical studies. Intensive Care Med. 2010 Sep;36(9):1475-83. doi: 10.1007/s00134-010-1929-y. Epub 2010 May 26.
PubMed 20502865Carrara M, Ferrario M, Bollen Pinto B, Herpain A. The autonomic nervous system in septic shock and its role as a future therapeutic target: a narrative review. Ann Intensive Care. 2021 May 17;11(1):80. doi: 10.1186/s13613-021-00869-7.
PubMed 33999297Boyd JH, Forbes J, Nakada TA, Walley KR, Russell JA. Fluid resuscitation in septic shock: a positive fluid balance and elevated central venous pressure are associated with increased mortality. Crit Care Med. 2011 Feb;39(2):259-65. doi: 10.1097/CCM.0b013e3181feeb15.
PubMed 20975548Boulain T, Boisrame-Helms J, Ehrmann S, Lascarrou JB, Bougle A, Chiche A, Lakhal K, Gaudry S, Perbet S, Desachy A, Cabasson S, Geneau I, Courouble P, Clavieras N, Massanet PL, Bellec F, Falquet Y, Reminiac F, Vignon P, Dequin PF, Meziani F. Volume expansion in the first 4 days of shock: a prospective multicentre study in 19 French intensive care units. Intensive Care Med. 2015 Feb;41(2):248-56. doi: 10.1007/s00134-014-3576-1. Epub 2014 Dec 2.
PubMed 25447804Boulain T, Achard JM, Teboul JL, Richard C, Perrotin D, Ginies G. Changes in BP induced by passive leg raising predict response to fluid loading in critically ill patients. Chest. 2002 Apr;121(4):1245-52. doi: 10.1378/chest.121.4.1245.
PubMed 11948060Aya HD, Ster IC, Fletcher N, Grounds RM, Rhodes A, Cecconi M. Pharmacodynamic Analysis of a Fluid Challenge. Crit Care Med. 2016 May;44(5):880-91. doi: 10.1097/CCM.0000000000001517.
PubMed 26683506Angus DC, van der Poll T. Severe sepsis and septic shock. N Engl J Med. 2013 Aug 29;369(9):840-51. doi: 10.1056/NEJMra1208623. No abstract available.
PubMed 23984731Amekran Y, Damoun N, El Hangouche AJ. A focus on the assessment of the autonomic function using heart rate variability. Glob Cardiol Sci Pract. 2025 Feb 28;2025(1):e202512. doi: 10.21542/gcsp.2025.12. eCollection 2025 Feb 28.
PubMed 40390990
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Systematic and Sequential Leg Elevation on Cardiac Output in Healthy Volunteers: A Single-Center Prospective Crossover Physiological Study
- ClinicalTrials.gov ID
- NCT07860515
- Acronym / sponsor ID
- SYSLE-1 / CHUO-2025-20
- Conditions
- Healthy Adult, Cardiac Output, Hemodynamic, Passive Leg Raising
- Keywords
- Passive leg raising, Cardiac Ouptut, Thoracic Bioreactance, Noninvasive Ventilation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 10 Jan 2029 (estimated)
- Study completion
- 10 Jan 2029 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Before 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.
SYSLE-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.
Detailed description
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.
In 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.
The 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.
Participants 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.
Cardiac 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Spontaneous Breathing | Experimental | Procedure: Passive Leg Raising, Procedure: Non-Invasive VentilationParticipants 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. Throughout 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. |
| Non-Invasive Ventilation | Experimental | Procedure: Passive Leg Raising, Procedure: Non-Invasive VentilationParticipants undergo one study day during non-invasive ventilation (NIV) delivered through an oronasal mask. Each 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. Continuous 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female participant.
- Age 18 years or older.
- Healthy volunteer without known acute or chronic disease.
- No significant cardiovascular or respiratory disease.
- No medication use within 10 days before the first study day (except oral contraceptives).
Key exclusion criteria (11 listed)
- Body mass index greater than 35 kg/m².
- Use of illicit psychoactive substances within the previous 3 months.
- Congenital or acquired absence of part or all of an upper or lower limb.
- Known allergy to hydrocolloid dressings.
- Pregnant or breastfeeding women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passive Leg RaisingPassive 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. | Procedure or surgery | Non-Invasive Ventilation, Spontaneous Breathing |
| Non-Invasive VentilationNon-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/kg predicted body weight (target 8-12 mL/kg). | Procedure or surgery | Non-Invasive Ventilation, Spontaneous Breathing |
Primary outcome
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
Time frame: 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.
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.
13 secondary outcomes
Change in cardiac output response across PLR sessions 1 to 6.
Time frame: 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.
Effect of ventilation mode on cardiac output response to passive leg raising
Time frame: During the two study days (up to 10 days apart). From enrollment to the end of study (day 2) at 3 months maximum.
Cardiac output evolution during passive leg raising
Time frame: During each 10-minute passive leg raising session. From enrollment to the end of study (day 2) at 3 months maximum
Effect of ventilation mode on cardiac output evolution during passive leg raising
Time frame: 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.
Cardiac output recovery after passive leg raising
Time frame: 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.
LF/HF ratio derived from heart rate variability.
Time frame: 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.
Change in brachial artery diameter measured by ultrasound.
Time frame: 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.
Agreement between cardiac output measurement methods (bioreactance, Clearsight®, echocardiography).
Time frame: During each study day, across all passive leg raising sessions. From enrollment to the end of study (day 2) at 3 months maximum.
Agreement between blood pressure measurement methods (oscillometry and Clearsight®).
Time frame: During each study day, across all passive leg raising sessions. From enrollment to the end of study (day 2) at 3 months maximum.
Correlation between end-tidal carbon dioxide and cardiac output during non-invasive ventilation
Time frame: During the non-invasive ventilation study day (approximately 6 hours). From enrollment to the end of study (day 2) at 3 months maximum.
Participant-reported discomfort,.
Time frame: Assessed during and after each passive leg raising session on both study days (approximately 6 hours / 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.
Participant-reported respiratory difficulty.
Time frame: 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.
Participant-reported pain.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 20502865Cavallaro F, Sandroni C, Marano C, La Torre G, Mannocci A, De Waure C, Bello G, Maviglia R, Antonelli M. Diagnostic accuracy of passive leg raising for prediction of fluid responsiveness in adults: systematic review and meta-analysis of clinical studies. Intensive Care Med. 2010 Sep;36(9):1475-83. doi: 10.1007/s00134-010-1929-y. Epub 2010 May 26.
- Background: PubMed 33999297Carrara M, Ferrario M, Bollen Pinto B, Herpain A. The autonomic nervous system in septic shock and its role as a future therapeutic target: a narrative review. Ann Intensive Care. 2021 May 17;11(1):80. doi: 10.1186/s13613-021-00869-7.
- Background: PubMed 20975548Boyd JH, Forbes J, Nakada TA, Walley KR, Russell JA. Fluid resuscitation in septic shock: a positive fluid balance and elevated central venous pressure are associated with increased mortality. Crit Care Med. 2011 Feb;39(2):259-65. doi: 10.1097/CCM.0b013e3181feeb15.
- Background: PubMed 25447804Boulain T, Boisrame-Helms J, Ehrmann S, Lascarrou JB, Bougle A, Chiche A, Lakhal K, Gaudry S, Perbet S, Desachy A, Cabasson S, Geneau I, Courouble P, Clavieras N, Massanet PL, Bellec F, Falquet Y, Reminiac F, Vignon P, Dequin PF, Meziani F. Volume expansion in the first 4 days of shock: a prospective multicentre study in 19 French intensive care units. Intensive Care Med. 2015 Feb;41(2):248-56. doi: 10.1007/s00134-014-3576-1. Epub 2014 Dec 2.
- Background: PubMed 11948060Boulain T, Achard JM, Teboul JL, Richard C, Perrotin D, Ginies G. Changes in BP induced by passive leg raising predict response to fluid loading in critically ill patients. Chest. 2002 Apr;121(4):1245-52. doi: 10.1378/chest.121.4.1245.
- Background: PubMed 26683506Aya HD, Ster IC, Fletcher N, Grounds RM, Rhodes A, Cecconi M. Pharmacodynamic Analysis of a Fluid Challenge. Crit Care Med. 2016 May;44(5):880-91. doi: 10.1097/CCM.0000000000001517.
- Background: PubMed 23984731Angus DC, van der Poll T. Severe sepsis and septic shock. N Engl J Med. 2013 Aug 29;369(9):840-51. doi: 10.1056/NEJMra1208623. No abstract available.
- Background: PubMed 40390990Amekran Y, Damoun N, El Hangouche AJ. A focus on the assessment of the autonomic function using heart rate variability. Glob Cardiol Sci Pract. 2025 Feb 28;2025(1):e202512. doi: 10.21542/gcsp.2025.12. eCollection 2025 Feb 28.
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Not yet recruiting
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Corneal Topography, Dry Eye Syndromes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mai-Anh PhD NAY, Physician principal investigator
Centre Hospitalier Régional d'Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive Leg Raising and Non-Invasive Ventilation in people with Healthy Adult and Cardiac Output, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mai-Anh PhD NAY, Physician (02.38.22.95.57 ext. +33, mai-anh.nay@chu-orleans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07860515, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.