Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06156943
NA

Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

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

Interventions

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

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