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Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery
Sponsor: Hospices Civils de Lyon
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.
Official title: Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery : a Multicenter, Randomized, Controlled Trial (AEGIS Study)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
722
Start Date
2024-12-12
Completion Date
2027-01
Last Updated
2024-12-24
Healthy Volunteers
No
Conditions
Interventions
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.
group managed by standard of care
Patients will be managed intraoperatively at the discretion of the attending anesthesiologists, in accordance with their institutional protocols
Locations (10)
Hopital Louis Pradel
Bron, France
CHU Dijon Bourgogne
Dijon, France
Hôpital Arnaud de Villeneuve - CHU Montpellier
Montpellier, France
Chu Nancy
Nancy, France
Hôpital Européen Georges Pompidou
Paris, France
Hopital du Haut-Leveque - CHU Bordeaux
Pessac, France
CHU de Rennes
Rennes, France
CHU Nantes
Saint-Herblain, France
CHU Strasbourg
Strasbourg, France
Chu Toulouse
Toulouse, France