NCT06156943

Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery

Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery : a Multicenter, Randomized, Controlled Trial (AEGIS Study)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 722 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

High-risk patients scheduled for lung resection 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. The impact of chest bioreactance on patients 'outcome remains however to be demonstrated. Indeed, the routine fluid management in patients undergoing lung resection surgery could be responsible of hypovolemia/hypoperfusion and/or hypervolemia/congestion leading to postoperative complications. 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 lung resection 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.

Conditions

• High-risk Lung Resection Surgery

Interventions

Type	Name	Description
PROCEDURE	individualized goal-directed fluid therapy by Starling device	For patients in optimized group, fluids will be managed by Starling device during the lung resection surgery.
PROCEDURE	group managed by standard of care	Patients will be managed intraoperatively at the discretion of the attending anesthesiologists, in accordance with their institutional protocols

Timeline

• Start date: 2024-12-12
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2023-12-05
• Last updated: 2024-12-24

Locations

10 sites across 1 country: France