Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery
NCT ID: NCT06156943
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
722 participants
INTERVENTIONAL
2024-12-12
2027-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Optimized group managed by the Starling device
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.
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.
Control group managed by standard of care
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).
group managed by standard of care
Patients will be managed intraoperatively at the discretion of the attending anesthesiologists, in accordance with their institutional protocols
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* High-risk patients (ASA score ≥ 3 and/or ventilatory deficit (defined as FEV1≤70% and/or VC≤70%) and/or AKI risk index ≥ III and/or modified clinical Lee Criteria ≥2) undergoing elective open-chest or video-assisted or robotic lung resection surgery
* Patients who have provided written informed consent to participate in the study
* Patients affiliated with a social health insurance
Exclusion Criteria
* Emergency surgery (Less than 24h)
* Patients unable to understand the purpose of the study
* Patients participating in another trial that would interfere with this study
* Female patients who are pregnant, lactating or women of child-bearing potential without effective methods of contraception
* Female patients with positive β-HCG blood test
* Patients under judicial protection (guardianship, curatorship)
18 Years
80 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Hopital Louis Pradel
Bron, , France
CHU Dijon Bourgogne
Dijon, , France
Hôpital Arnaud de Villeneuve - CHU Montpellier
Montpellier, , France
Chu Nancy
Nancy, , France
Hôpital Européen Georges Pompidou
Paris, , France
Hopital du Haut-Leveque - CHU Bordeaux
Pessac, , France
CHU de Rennes
Rennes, , France
CHU Nantes
Saint-Herblain, , France
CHU Strasbourg
Strasbourg, , France
Chu Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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FELLAHI Jean-Luc, MD. PhD
Role: primary
Guinot Pierre, MD
Role: primary
Godard Philippe, MD
Role: primary
GUERCI PHILIPPE
Role: primary
Bernard Cholley, MD
Role: primary
Ouattara Alexandre, MD
Role: primary
Nesseler Nicolas, MD
Role: primary
Bertrand Rozec, MD
Role: primary
Michel Mertes, MD
Role: primary
LABASTE François, MD
Role: primary
Other Identifiers
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2024-A01843-44
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL22_1133
Identifier Type: -
Identifier Source: org_study_id