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Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery

RecruitingNAAges 18 Years - 80 YearsAllHospices Civils de Lyon
NCT06156943 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 signifi

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • individualized goal-directed fluid therapy by Starling device
  • group managed by standard of care
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Where

10 sites
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

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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