Brief Summary

High-risk patients scheduled for thoracic cancer 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. To know if chest bioreactance could be used to conduct perioperative GDFT and impact patients 'outcome remains however to be demonstrated.

Indeed, the routine fluid management in patients undergoing thoracic cancer surgery could be responsible of hypovolemia/hypoperfusion and/or hypervolemia/congestion leading to postoperative complications and poor outcomes.

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 thoracic cancer 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.

Conditions

• High-risk Thoracic Cancer Surgery

Intervention / Treatment

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

Primary Outcome Measures

• A composite of postoperative complications rate adapted from the Clavien-Dindo classification with only events ≥ class II (Within 30 days after the surgery)
  It will be performed in each group and assessed by an independent adjudication committee. Clavien-Dindo classification : Class II : * Pulmonary complications (any infection requiring antibiotics, non-invasive ventilation) * Cardiovascular complications (postoperative atrial fibrillation (POAF) requiring treatment, deep venous thrombosis) * Renal complications (acute kidney injury (AKI) stages 1 to 3 requiring fluid challenge or diuretics) * Cerebral complications (delirium requiring treatment, stroke) * Blood products transfusion Class III * Reoperation from any cause Class IV * Any admission to the intensive care unit (ICU) Class V * Mortality from any cause The analysis of the main endpoint will be performed by a mixed logistic regression model. It will take into account as explanatory variable the intervention, as well as the type of surgery (open-chest or video-assisted). It will include a random intercept by center.

Countries

France

Locations and Investigators

• Hopital Louis Pradel, Bron, France
  • FELLAHI Jean-Luc, MD. PhD
• CHU CAEN, Caen, France
  • Marc-Olivier Fischer
• CHU Dijon Bourgogne, Dijon, France
  • Guinot Pierre, MD
• Hopital Nord - Assistance Publique - Hopitaux de Marseille, Marseille, France
  • Marc Leone, MD
• Hôpital Arnaud de Villeneuve - CHU Montpellier, Montpellier, France
  • Godard Philippe, MD
• Hôpital Européen Georges Pompidou, Paris, France
  • Bernard Cholley, MD
• Hôpital Bichat, Paris, France
  • Dan Longrois, MD
• Hopital du Haut-Leveque - CHU Bordeaux, Pessac, France
  • Ouattara Alexandre, MD
• CHU de Rennes, Rennes, France
• CHU Nantes, Saint-Herblain, France
  • Bertrand Rozec, MD
• CHU Strasbourg, Strasbourg, France
  • Michel Mertes, MD