Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery (AEGIS)

Civil Hospices of Lyon

Status: Enrolling

Conditions: High-risk Lung Resection Surgery

Treatments: Procedure: individualized goal-directed fluid therapy by Starling device; Procedure: group managed by standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT06156943

2024-A01843-44 (Other Identifier)

69HCL22_1133

Details and patient eligibility

About

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.

Enrollment: 722 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (≥ 18 years old)
• 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

• Pleural or mediastinal resection surgery
• 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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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722 participants in 2 patient groups

Optimized group managed by the Starling device

Experimental group

Description:

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.

Treatment:

Procedure: individualized goal-directed fluid therapy by Starling device

Control group managed by standard of care

Other group

Description:

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).

Treatment:

Procedure: group managed by standard of care