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In the optimized group, patients will be managed intraoperatively with the Starling device. It is a non-invasive fluid management monitoring system provides continuous hemodynamic monitoring and empowers fluid management across the continuum of care. Thanks to this device, patients will be managed according to the following protocol: fluid responsiveness will be systematically assessed by repetitive fluid challenges (2-3 ml/kg of Ringer Lactate) given to increase SV by at least 10% when mean arterial pressure falls below 65 mmHg and/or perfusion index falls below 1.5. Vasoactive and/or inotropic agents will be used at the discretion of the attending anesthesiologists in case of fluid unresponsiveness.

In the control group, patients will be managed intraoperatively at the discretion of the attending anesthesiologists, in accordance with their institutional protocols (i.e. fluids and/or vasoactive agents are given to maintain mean arterial pressure ≥ 65 mmHg).

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

individualized goal-directed fluid therapy by Starling device

Patients will be managed intraoperatively at the discretion of the attending anesthesiologists, in accordance with their institutional protocols

group managed by standard of care

FELLAHI Jean-Luc, M.D., Ph.D.,

SAMSON Géraldine

FELLAHI Jean-Luc, MD. PhD

Marc-Olivier Fischer

Guinot Pierre, MD

Marc Leone, MD

Godard Philippe, MD

Bernard Cholley, MD

Dan Longrois, MD

Ouattara Alexandre, MD

Bertrand Rozec, MD

Michel Mertes, MD

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.

National prospective multicenter randomized simple blind controlled study comparing a standard of care (control group) to an individualized strategy of intraoperative GDFT driven by non-invasive continuous SV monitoring via chest bioreactance (optimized group).

The patients are the only ones masked. As double blind is not possible, an adjudication committee, whose members will be unaware of the procedure assignments, will adjudicate all the clinical outcomes.

Impact of Non-invasive Individualized Goal-directed Fluid Therapy on Outcomes Following Thoracic Cancer Surgery

Impact of Non-invasive Individualized Goal-directed Fluid Therapy on Outcomes Following Thoracic Cancer Surgery: A Multicenter, Randomized, Controlled Study

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.

Items of the primary composite endpoint :

- Pulmonary complications rate

Each item of the primary composite endpoint will be described in each group in terms of number/percentage of patients and compared using the chi-2 test or the exact test of Fisher. An Holm correction will be applied to take into account multiple testing.

Items of the primary composite endpoint :

- Cardiovascular complications rate

Each item of the primary composite endpoint will be described in each group in terms of number/percentage of patients and compared using the chi-2 test or the exact test of Fisher. An Holm correction will be applied to take into account multiple testing.

Items of the primary composite endpoint :

- Renal complications rate

Each item of the primary composite endpoint will be described in each group in terms of number/percentage of patients and compared using the chi-2 test or the exact test of Fisher. An Holm correction will be applied to take into account multiple testing.

Items of the primary composite endpoint :

- Cerebral complications rate

Each item of the primary composite endpoint will be described in each group in terms of number/percentage of patients and compared using the chi-2 test or the exact test of Fisher. An Holm correction will be applied to take into account multiple testing.

Items of the primary composite endpoint :

- Blood products transfusion rate

Each item of the primary composite endpoint will be described in each group in terms of number/percentage of patients and compared using the chi-2 test or the exact test of Fisher. An Holm correction will be applied to take into account multiple testing.

Items of the primary composite endpoint :

- Reoperation from any cause rate

Each item of the primary composite endpoint will be described in each group in terms of number/percentage of patients and compared using the chi-2 test or the exact test of Fisher. An Holm correction will be applied to take into account multiple testing.

Items of the primary composite endpoint :

- Any admission to the ICU rate

Each item of the primary composite endpoint will be described in each group in terms of number/percentage of patients and compared using the chi-2 test or the exact test of Fisher. An Holm correction will be applied to take into account multiple testing.

Items of the primary composite endpoint :

- Mortality rate

Each item of the primary composite endpoint will be described in each group in terms of number/percentage of patients and compared using the chi-2 test or the exact test of Fisher. An Holm correction will be applied to take into account multiple testing.

Quantitative secondary endpoints will be described in each group, and will be compared between the two groups using the t test of Student or the test of Mann and Whitney, according to the shape of the distribution.

Qualitative secondary outcome will be described in each group by the number/percentage of patients and compared using the chi-2 test or the exact test of Fisher.

Spots Global Cancer Trial Database for group managed by standard of care