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NOT YET RECRUITING
NCT07860515
NA

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

Sponsor: Centre Hospitalier Régional d'Orléans

View on ClinicalTrials.gov

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.

Official title: Effect of Systematic and Sequential Leg Elevation on Cardiac Output in Healthy Volunteers: A Single-Center Prospective Crossover Physiological Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-10-10

Completion Date

2029-01-10

Last Updated

2026-10-06

Healthy Volunteers

Yes

Interventions

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.

PROCEDURE

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).

Locations (1)

Centre Hospitalier Régional d'Orléans

Orléans, Loiret, France