Informations générales (source: ClinicalTrials.gov)
Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery : a Multicenter, Randomized, Controlled Trial (AEGIS Study) (AEGIS)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
décembre 2024
janvier 2027
05 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Europeen Georges Pompidou | Bernard Cholley, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Rennes - 35033 - Rennes - France | Nesseler Nicolas, MD | Contact (sur clinicalTrials) | |||
| CHU Dijon Bourgogne - 21000 - Dijon - France | Guinot Pierre, MD | Contact (sur clinicalTrials) | |||
| Chu Nancy - Nancy - France | GUERCI PHILIPPE | Contact (sur clinicalTrials) | |||
| CHU Nantes - 44800 - Saint-Herblain - France | Bertrand Rozec, MD | Contact (sur clinicalTrials) | |||
| CHU Strasbourg - 67000 - Strasbourg - France | Michel Mertes, MD | Contact (sur clinicalTrials) | |||
| Chu Toulouse - Toulouse - France | LABASTE François, MD | Contact (sur clinicalTrials) | |||
| Hôpital Arnaud de Villeneuve - CHU Montpellier - 34090 - Montpellier - France | Godard Philippe, MD | Contact (sur clinicalTrials) | |||
| Hopital du Haut-Leveque - CHU Bordeaux - 33600 - Pessac - France | Ouattara Alexandre, MD | Contact (sur clinicalTrials) | |||
| Hopital Louis Pradel - 69500 - Bron - France | FELLAHI Jean-Luc, MD. PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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)