Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06156943

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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