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Effect of Systematic and Sequential Leg Elevation on Cardiac Output in Healthy Volunteers

ConditionsHealthy AdultCardiac OutputHemodynamicPassive Leg Raising
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Régional d'Orléans

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female participant.

Age 18 years or older.

Healthy volunteer without known acute or chronic disease.

No significant cardiovascular or respiratory disease.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Passive Leg Raising

    Procedure/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 Ventilation

    Procedure/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).

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Spontaneous BreathingExperimental treatment 2 interventions
Group B: Non-Invasive VentilationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

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.

Secondary outcomes

1

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.

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.
2

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.

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.
3

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.

Time frame
During each 10-minute passive leg raising session. From enrollment to the end of study (day 2) at 3 months maximum
4

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.

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Régional d'Orléans

Lead sponsor

Source ClinicalTrials.gov

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