Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery

Recruiting now · Not applicable

Conditions studied: High-risk Lung Resection Surgery

In brief

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.

Key facts

Study ID

NCT06156943

Run by

Hospices Civils de Lyon

People needed

722

Starts

2024-12-12

Expected to finish

2027-01-01

Last updated by the study team

2024-12-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Hopital Louis Pradel — Bron, France (enrolling)
• CHU Dijon Bourgogne — Dijon, France (enrolling)
• Hôpital Arnaud de Villeneuve - CHU Montpellier — Montpellier, France (enrolling)
• Chu Nancy — Nancy, France (enrolling)
• Hôpital Européen Georges Pompidou — Paris, France (enrolling)
• Hopital du Haut-Leveque - CHU Bordeaux — Pessac, France (enrolling)
• CHU de Rennes — Rennes, France (enrolling)
• CHU Nantes — Saint-Herblain, France (enrolling)
• CHU Strasbourg — Strasbourg, France (enrolling)
• Chu Toulouse — Toulouse, France (enrolling)

Full record on ClinicalTrials.gov

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