Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

individualized goal-directed fluid therapy by Starling device: For patients in optimized group, fluids will be managed by Starling device during the lung resection surgery.

group managed by standard of care: Patients will be managed intraoperatively at the discretion of the attending anesthesiologists, in accordance with their institutional protocols

Study 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

Primary outcome measure(s)

• 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), defined as an increase of serum creatinine of more than 50% or more than 26.5 µmol/L, requiring fluid supply or diuretics) * Cerebral complications (delirium requiring treatment, stroke) * Blood products transfusion Class III * Reoperation from any cause Class IV * Any unscheduled 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 or robotic). It will include

Trial sites (10)

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