RecruitingNot ApplicableNCT06156943

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)


Sponsor

Hospices Civils de Lyon

Enrollment

722 participants

Start Date

Dec 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • Adults (≥ 18 years old)
  • High-risk patients (ASA score ≥ 3 and/or ventilatory deficit (defined as FEV1≤70% and/or VC≤70%) and/or AKI risk index ≥ III and/or modified clinical Lee Criteria ≥2) undergoing elective open-chest or video-assisted or robotic lung resection surgery
  • Patients who have provided written informed consent to participate in the study
  • Patients affiliated with a social health insurance

Exclusion Criteria7

  • Pleural or mediastinal resection surgery
  • Emergency surgery (Less than 24h)
  • Patients unable to understand the purpose of the study
  • Patients participating in another trial that would interfere with this study
  • Female patients who are pregnant, lactating or women of child-bearing potential without effective methods of contraception
  • Female patients with positive β-HCG blood test
  • Patients under judicial protection (guardianship, curatorship)

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Interventions

PROCEDUREindividualized goal-directed fluid therapy by Starling device

For patients in optimized group, fluids will be managed by Starling device during the lung resection surgery.

PROCEDUREgroup 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

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NCT06156943