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Advanced Goal-Directed Fluid Management Using the Starling Device for Patients Undergoing Lung Resection Surgery: A National Randomized Trial
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
Researchers are studying high-risk patients scheduled for lung resection surgery to see if using an individualized goal-directed fluid therapy (GDFT) guided by chest bioreactance improves outcomes within 30 days after surgery. Lung surgery poses challenges for monitoring stroke volume and cardiac output due to patient positioning and surgical conditions. Chest bioreactance offers a non-invasive, continuous way to monitor these heart functions, but its impact on patient outcomes has yet to be proven. During the study, patients will be randomly assigned to one of two groups. One group will receive fluid management guided by the Starling device using chest bioreactance during lung resection surgery. The other group will be managed according to standard care protocols as decided by the attending anesthesiologists. Because double blinding is not possible, an independent committee unaware of treatment assignments will review all clinical outcomes. Participants will be monitored for postoperative complications within 30 days after surgery using a classification system. Researchers will collect data on complications of severity class II or higher. The study includes adults aged 18 to 80 who are at high risk based on health scores and lung function. Patient consent and social health insurance affiliation are required. The total participation includes the surgery period and a 30-day postoperative follow-up to assess safety and complications.
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
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Trial Site Locations
Total: 10 locations
1
Hopital Louis Pradel
Bron, France, 69500
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2
CHU Dijon Bourgogne
Dijon, France, 21000
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3
Hôpital Arnaud de Villeneuve - CHU Montpellier
Montpellier, France, 34090
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4
Chu Nancy
Nancy, France
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5
Hôpital Européen Georges Pompidou
Paris, France, 75015
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6
Hopital du Haut-Leveque - CHU Bordeaux
Pessac, France, 33600
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7
CHU de Rennes
Rennes, France, 35033
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8
CHU Nantes
Saint-Herblain, France, 44800
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9
CHU Strasbourg
Strasbourg, France, 67000
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10
Chu Toulouse
Toulouse, France
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Research Team
F
FELLAHI Jean-Luc, M.D., Ph.D.,
S
SAMSON Géraldine
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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