Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06156943

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

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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

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.,

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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