Spots Global Cancer Trial Database for Impact of Non-invasive Individualized Goal-directed Fluid Therapy on Outcomes Following Thoracic Cancer Surgery

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Trial Identification

Brief Title: Impact of Non-invasive Individualized Goal-directed Fluid Therapy on Outcomes Following Thoracic Cancer Surgery

Official Title: Impact of Non-invasive Individualized Goal-directed Fluid Therapy on Outcomes Following Thoracic Cancer Surgery: A Multicenter, Randomized, Controlled Study

Study ID: NCT06156943

Conditions

High-risk Thoracic Cancer Surgery

Interventions

individualized goal-directed fluid therapy by Starling device

group managed by standard of care

Study Description

Brief Summary: High-risk patients scheduled for thoracic cancer surgery are increasing and theoretically eligible to perioperative individualized goal-directed fluid therapy (GDFT). However, thoracic surgery is challenging for intraoperative stroke volume (SV) and/or cardiac output monitoring because it requires lateral positioning, one-lung ventilation, and open-chest condition. Pulse contour analysis and esophageal Doppler have been proposed with contrasting results, whereas dynamic indices have been shown useless for predicting fluid responsiveness in that specific setting. Besides, more invasive technologies like thermodilution are not routinely used at the bedside by careproviders. Chest bioreactance seems to be a feasible, safe, rustic, easy-to-use, and plug-and-play method to non-invasively and continuously monitor SV and cardiac output in thoracic cancer surgery patients, able to detect significant spontaneous and pharmacologically-induced changes over time. To know if chest bioreactance could be used to conduct perioperative GDFT and impact patients 'outcome remains however to be demonstrated. Indeed, the routine fluid management in patients undergoing thoracic cancer surgery could be responsible of hypovolemia/hypoperfusion and/or hypervolemia/congestion leading to postoperative complications and poor outcomes. The present national prospective multicenter randomized simple blind study aims to demonstrate that an individualized goal-directed fluid therapy (GDFT) driven by chest bioreactance improves outcomes within 30 days in thoracic cancer surgery patients when compared with a standard of care. As double blind is not possible, an adjudication committee, whose members will be unaware of the procedure assignments, will adjudicate all the clinical outcomes.

Detailed Description: