Using chest bioreactance to improve fluid therapy in lung surgery
Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery : a Multicenter, Randomized, Controlled Trial (AEGIS Study)
This study tests if using a new chest monitoring device can help doctors give better fluid treatment to patients having lung surgery, compared to the usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 722 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 10 sites (Bron and 9 other locations) |
| Trial ID | NCT06156943 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of chest bioreactance technology to monitor stroke volume and cardiac output in high-risk patients undergoing lung resection surgery. The study aims to implement individualized goal-directed fluid therapy (GDFT) based on real-time monitoring, contrasting it with standard care practices. By utilizing a non-invasive and continuous monitoring approach, the trial seeks to enhance perioperative management and outcomes for patients facing complex thoracic surgeries.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with high-risk profiles undergoing elective lung resection surgery.
Not a fit: Patients undergoing emergency surgeries or those with specific exclusion criteria such as pleural or mediastinal resection surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved fluid management and better surgical outcomes for high-risk lung surgery patients.
How similar studies have performed: While the use of chest bioreactance is a relatively novel approach in this context, other studies have shown promise in utilizing non-invasive monitoring techniques for fluid management.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Bron and 9 other locations
- Hopital Louis Pradel — Bron, France (Recruiting)
- CHU Dijon Bourgogne — Dijon, France (Recruiting)
- Hôpital Arnaud de Villeneuve - CHU Montpellier — Montpellier, France (Recruiting)
- Chu Nancy — Nancy, France (Recruiting)
- Hôpital Européen Georges Pompidou — Paris, France (Recruiting)
- Hopital du Haut-Leveque - CHU Bordeaux — Pessac, France (Recruiting)
- CHU de Rennes — Rennes, France (Recruiting)
- CHU Nantes — Saint-Herblain, France (Recruiting)
- CHU Strasbourg — Strasbourg, France (Recruiting)
- Chu Toulouse — Toulouse, France (Recruiting)
Study contacts
- Study coordinator: FELLAHI Jean-Luc, M.D., Ph.D.,
- Email: jean-luc.fellahi@chu-lyon.fr
- Phone: (+33) 4 72 11 89 33
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.