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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01843-44 | Other Identifier | ID-RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optimized group managed by the Starling device | Experimental | In the optimized group, patients will be managed intraoperatively with the Starling device according to the Société Française d'Anesthésie Réanimation 2024 GDFT protocol (Alter C. https://sfar.org/optimisation-hemodynamique-perioperatoire-adulte-dont-obstetrique/). 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 after anesthetic induction and throughout the procedure as soon as the basal SV monitored by the Starling device decrease by at least 10%. To do so, repetitive fluid challenges (200 ± 50 ml of cristalloids) will be quickly delivered until SV stops to increase by 10% or more. Vasoactive and/or inotropic agents will be used at the discretion of the attending anesthesiologists in case of fluid unresponsiveness. |
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| Control group managed by standard of care | Other | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| individualized goal-directed fluid therapy by Starling device | Procedure | For patients in optimized group, fluids will be managed by Starling device during the lung resection surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| A 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 :
| Within 30 days after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 30 days after the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| FELLAHI Jean-Luc, M.D., Ph.D., | Contact | (+33) 4 72 11 89 33 | jean-luc.fellahi@chu-lyon.fr | |
| SAMSON Géraldine | Contact | (+33) 4.27.85.53.26 | Geraldine.samson@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Louis Pradel | Recruiting | Bron | 69500 | France |
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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).
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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.
| group managed by standard of care | Procedure | Patients will be managed intraoperatively at the discretion of the attending anesthesiologists, in accordance with their institutional protocols |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 1 day |
| CHU Dijon Bourgogne | Recruiting | Dijon | 21000 | France |
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| Hôpital Arnaud de Villeneuve - CHU Montpellier | Recruiting | Montpellier | 34090 | France |
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| Chu Nancy | Recruiting | Nancy | France |
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| Hôpital Européen Georges Pompidou | Recruiting | Paris | 75015 | France |
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| Hopital du Haut-Leveque - CHU Bordeaux | Recruiting | Pessac | 33600 | France |
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| CHU de Rennes | Recruiting | Rennes | 35033 | France |
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| CHU Nantes | Recruiting | Saint-Herblain | 44800 | France |
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| CHU Strasbourg | Recruiting | Strasbourg | 67000 | France |
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| Chu Toulouse | Recruiting | Toulouse | France |
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