Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery : a Multicenter, Randomized, Controlled Trial (AEGIS Study)

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hopital Louis Pradel
RECRUITING
Bron
CHU Dijon Bourgogne
RECRUITING
Dijon
Hôpital Arnaud de Villeneuve - CHU Montpellier
RECRUITING
Montpellier
Chu Nancy
RECRUITING
Nancy
Hôpital Européen Georges Pompidou
RECRUITING
Paris
Hopital du Haut-Leveque - CHU Bordeaux
RECRUITING
Pessac
CHU de Rennes
RECRUITING
Rennes
CHU Nantes
RECRUITING
Saint-herblain
CHU Strasbourg
RECRUITING
Strasbourg
Chu Toulouse
RECRUITING
Toulouse
Contact Information
Primary
FELLAHI Jean-Luc, M.D., Ph.D.,
jean-luc.fellahi@chu-lyon.fr
(+33) 4 72 11 89 33
Backup
SAMSON Géraldine
Geraldine.samson@chu-lyon.fr
(+33) 4.27.85.53.26
Time Frame
Start Date: 2024-12-12
Estimated Completion Date: 2027-01
Participants
Target number of participants: 722
Treatments
Experimental: 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.
Other: 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).
Related Therapeutic Areas
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov