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ClinicalTrials.gov ID

NCT06156943

Lead Sponsor

Hospices Civils de LyonOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

722Estimated

Last Update Posted

Dec 24, 2024Actual

Start Date

Dec 12, 2024Actual

Primary Completion Date

Jan 2027Estimated

Completion Date

Jan 2027Estimated

Official Title

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

Brief 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.

• High-risk Lung Resection Surgery

• individualized goal-directed fluid therapy by Starling device
• group managed by standard of care

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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)

Primary Purpose

Other

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Hospices Civils de LyonOTHER

p.guerci@chru-nancy.fr+33 3 83 85 18 13

labaste.f@chu-toulouse.fr+33 5 61 32 27 91