Clinical trial NCT06156943: Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery
Official title: Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery : a Multicenter, Randomized, Controlled Trial (AEGIS Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High-risk Lung Resection Surgery
Keywords: goal-directed fluid therapy
Chest bioreactance
lung resection surgery
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 722
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: National prospective multicenter randomized simple blind controlled study comparing a standard of care (control group) to an individualized strategy of intraoperative GDFT driven by non-invasive continuous SV monitoring via chest bioreactance (optimized group).
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: A composite of postoperative complications rate adapted from the Clavien-Dindo classification with only events ≥ class II
timeFrame: Within 30 days after the surgery
Secondary outcomes:
measure: Each item of the primary composite endpoint between both groups
timeFrame: Within 30 days after the surgery
measure: Each item of the primary composite endpoint between both groups
timeFrame: Within 30 days after the surgery
measure: Each item of the primary composite endpoint between both groups
timeFrame: Within 30 days after the surgery
measure: Each item of the primary composite endpoint between both groups
timeFrame: Within 30 days after the surgery
measure: Each item of the primary composite endpoint between both groups
timeFrame: Within 30 days after the surgery
measure: Each item of the primary composite endpoint between both groups
timeFrame: Within 30 days after the surgery
measure: Each item of the primary composite endpoint between both groups
timeFrame: Within 30 days after the surgery
measure: Each item of the primary composite endpoint between both groups
timeFrame: Within 30 days after the surgery
measure: Length of stay in hospital (days) and number/percentage of patients with length of stay in hospital ≥ 5 days in each group
timeFrame: 5 days
measure: APGAR surgical score and number/percentage of patients with APGAR surgical score < 7 in each group
timeFrame: 1 day
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Louis Pradel
city: Dijon
country: France
facility: CHU Dijon Bourgogne
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve - CHU Montpellier
city: Nancy
country: France
facility: Chu Nancy
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Pessac
country: France
facility: Hopital du Haut-Leveque - CHU Bordeaux
city: Rennes
country: France
facility: CHU de Rennes
city: Saint-Herblain
country: France
facility: CHU Nantes
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulouse
country: France
facility: Chu Toulouse
Study officials:
References: