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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
722
For patients in optimized group, fluids will be managed by Starling device during the lung resection surgery.
Patients will be managed intraoperatively at the discretion of the attending anesthesiologists, in accordance with their institutional protocols
Hopital Louis Pradel
Bron, France
RECRUITINGCHU Dijon Bourgogne
Dijon, France
RECRUITINGHôpital Arnaud de Villeneuve - CHU Montpellier
Montpellier, France
RECRUITINGChu Nancy
Nancy, France
RECRUITINGHôpital Européen Georges Pompidou
Paris, France
RECRUITINGHopital du Haut-Leveque - CHU Bordeaux
Pessac, France
RECRUITINGCHU de Rennes
Rennes, France
RECRUITINGCHU Nantes
Saint-Herblain, France
RECRUITINGCHU Strasbourg
Strasbourg, France
RECRUITINGChu Toulouse
Toulouse, France
RECRUITINGA composite of postoperative complications rate adapted from the Clavien-Dindo classification with only events ≥ class II
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
Time frame: Within 30 days after the surgery
Each item of the primary composite endpoint between both groups
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.
Time frame: Within 30 days after the surgery
Each item of the primary composite endpoint between both groups
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.
Time frame: Within 30 days after the surgery
Each item of the primary composite endpoint between both groups
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.
Time frame: Within 30 days after the surgery
Each item of the primary composite endpoint between both groups
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.
Time frame: Within 30 days after the surgery
Each item of the primary composite endpoint between both groups
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.
Time frame: Within 30 days after the surgery
Each item of the primary composite endpoint between both groups
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.
Time frame: Within 30 days after the surgery
Each item of the primary composite endpoint between both groups
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.
Time frame: Within 30 days after the surgery
Each item of the primary composite endpoint between both groups
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.
Time frame: Within 30 days after the surgery
Length of stay in hospital (days) and number/percentage of patients with length of stay in hospital ≥ 5 days in each group
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.
Time frame: 5 days
APGAR surgical score and number/percentage of patients with APGAR surgical score < 7 in each group
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.
Time frame: 1 day
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