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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Non-Invasive Ventilation: 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 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.

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

Primary outcome measure(s)

• 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 — 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.

Trial sites (1)

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