Lyon Civilian Hospices
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.
High-risk Lung Resection Surgery
individualized goal-directed fluid therapy by Starling device
group managed by standard of care
NA
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 722 participants |
| Masking : | SINGLE |
| Masking Description : | The patients are the only ones masked. As double blind is not possible, an adjudication committee, whose members will be unaware of the procedure assignments, will adjudicate all the clinical outcomes. |
| Primary Purpose : | OTHER |
| Official Title : | Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery : a Multicenter, Randomized, Controlled Trial (AEGIS Study) |
| Actual Study Start Date : | 2024-12-12 |
| Estimated Primary Completion Date : | 2027-01 |
| Estimated Study Completion Date : | 2027-01 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 80 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
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Louis Pradel hospital
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Chu dijon bourgogne
Dijon, France, 21000
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Nancy, France,
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European Hospital Georges Pompidou
Paris, France, 75015
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Haut -Leveque hospital - CHU Bordeaux
Pessac, France, 33600
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Rennes of Chu
Rennes, France, 35033
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Saint-Herblain, France, 44800
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CHU Strasbourg
Strasbourg, France, 67000
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He was shaking
Toulouse, France,