Actively Recruiting
Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery
Led by Hospices Civils de Lyon · Updated on 2024-12-24
722
Participants Needed
10
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (18 years old or older)
- High-risk patients with ASA score 3 or higher and/or ventilatory deficit (FEV1 ≤70% and/or VC ≤70%) and/or AKI risk index 3 or higher and/or modified clinical Lee Criteria 2 or higher
- Undergoing elective open-chest, video-assisted, or robotic lung resection surgery
- Provided written informed consent to participate
- Affiliated with social health insurance
You will not qualify if you...
- Pleural or mediastinal resection surgery
- Emergency surgery scheduled within less than 24 hours
- Unable to understand the purpose of the study
- Participating in another trial that would interfere with this study
- Female patients who are pregnant, lactating, or women of child-bearing potential without effective contraception
- Female patients with a positive beta-HCG blood test
- Patients under judicial protection such as guardianship or curatorship
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Hopital Louis Pradel
Bron, France, 69500
Actively Recruiting
2
CHU Dijon Bourgogne
Dijon, France, 21000
Actively Recruiting
3
Hôpital Arnaud de Villeneuve - CHU Montpellier
Montpellier, France, 34090
Actively Recruiting
4
Chu Nancy
Nancy, France
Actively Recruiting
5
Hôpital Européen Georges Pompidou
Paris, France, 75015
Actively Recruiting
6
Hopital du Haut-Leveque - CHU Bordeaux
Pessac, France, 33600
Actively Recruiting
7
CHU de Rennes
Rennes, France, 35033
Actively Recruiting
8
CHU Nantes
Saint-Herblain, France, 44800
Actively Recruiting
9
CHU Strasbourg
Strasbourg, France, 67000
Actively Recruiting
10
Chu Toulouse
Toulouse, France
Actively Recruiting
Research Team
F
FELLAHI Jean-Luc, M.D., Ph.D.,
CONTACT
S
SAMSON Géraldine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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