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NCT Number: NCT06156943

Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery

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.

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Key information

Conditions

High-risk Lung Resection Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Louis Pradel, Bron, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

individualized goal-directed fluid therapy by Starling device

Procedure

For patients in optimized group, fluids will be managed by Starling device during the lung resection surgery.

group managed by standard of care

Procedure

Patients will be managed intraoperatively at the discretion of the attending anesthesiologists, in accordance with their institutional protocols

Primary outcomes

  1. A composite of postoperative complications rate adapted from the Clavien-Dindo classification with only events ≥ class II

    Time frame: Within 30 days after the surgery

    It will be performed in each group and assessed by an independent adjudication committee.

    Clavien-Dindo classification :

    Class II :

    • Pulmonary complications (any infection requiring antibiotics, non-invasive ventilation)
    • Cardiovascular complications (postoperative atrial fibrillation (POAF) requiring treatment, deep venous thrombosis)
    • Renal complications (acute kidney injury (AKI), defined as an increase of serum creatinine of more than 50% or more than 26.5 µmol/L, requiring fluid supply or diuretics)
    • Cerebral complications (delirium requiring treatment, stroke)
    • Blood products transfusion Class III
    • Reoperation from any cause Class IV
    • Any unscheduled admission to the intensive care unit (ICU) Class V
    • Mortality from any cause The analysis of the main endpoint will be performed by a mixed logistic regression model. It will take into account as explanatory variable the intervention, as well as the type of surgery (open-chest or video-assisted or robotic). It will include

Secondary outcomes

  1. Each item of the primary composite endpoint between both groups

    Time frame: Within 30 days after the surgery

    Items of the primary composite endpoint :

    • Pulmonary complications rate

    Each item of the primary composite endpoint will be described in each group in terms of number/percentage of patients and compared using the chi-2 test or the exact test of Fisher. An Holm correction will be applied to take into account multiple testing.

  2. Each item of the primary composite endpoint between both groups

    Time frame: Within 30 days after the surgery

    Items of the primary composite endpoint :

    • Cardiovascular complications rate

    Each item of the primary composite endpoint will be described in each group in terms of number/percentage of patients and compared using the chi-2 test or the exact test of Fisher. An Holm correction will be applied to take into account multiple testing.

  3. Each item of the primary composite endpoint between both groups

    Time frame: Within 30 days after the surgery

    Items of the primary composite endpoint :

    • Renal complications rate

    Each item of the primary composite endpoint will be described in each group in terms of number/percentage of patients and compared using the chi-2 test or the exact test of Fisher. An Holm correction will be applied to take into account multiple testing.

  4. Each item of the primary composite endpoint between both groups

    Time frame: Within 30 days after the surgery

    Items of the primary composite endpoint :

    • Cerebral complications rate

    Each item of the primary composite endpoint will be described in each group in terms of number/percentage of patients and compared using the chi-2 test or the exact test of Fisher. An Holm correction will be applied to take into account multiple testing.

  5. Each item of the primary composite endpoint between both groups

    Time frame: Within 30 days after the surgery

    Items of the primary composite endpoint :

    • Blood products transfusion rate

    Each item of the primary composite endpoint will be described in each group in terms of number/percentage of patients and compared using the chi-2 test or the exact test of Fisher. An Holm correction will be applied to take into account multiple testing.

  6. Each item of the primary composite endpoint between both groups

    Time frame: Within 30 days after the surgery

    Items of the primary composite endpoint :

    • Reoperation from any cause rate

    Each item of the primary composite endpoint will be described in each group in terms of number/percentage of patients and compared using the chi-2 test or the exact test of Fisher. An Holm correction will be applied to take into account multiple testing.

  7. Each item of the primary composite endpoint between both groups

    Time frame: Within 30 days after the surgery

    Items of the primary composite endpoint :

    • Any admission to the ICU rate

    Each item of the primary composite endpoint will be described in each group in terms of number/percentage of patients and compared using the chi-2 test or the exact test of Fisher. An Holm correction will be applied to take into account multiple testing.

  8. Each item of the primary composite endpoint between both groups

    Time frame: Within 30 days after the surgery

    Items of the primary composite endpoint :

    • Mortality rate

    Each item of the primary composite endpoint will be described in each group in terms of number/percentage of patients and compared using the chi-2 test or the exact test of Fisher. An Holm correction will be applied to take into account multiple testing.

  9. Length of stay in hospital (days) and number/percentage of patients with length of stay in hospital ≥ 5 days in each group

    Time frame: 5 days

    Quantitative secondary endpoints will be described in each group, and will be compared between the two groups using the t test of Student or the test of Mann and Whitney, according to the shape of the distribution.

    Qualitative secondary outcome will be described in each group by the number/percentage of patients and compared using the chi-2 test or the exact test of Fisher.

  10. APGAR surgical score and number/percentage of patients with APGAR surgical score < 7 in each group

    Time frame: 1 day

    Quantitative secondary endpoints will be described in each group, and will be compared between the two groups using the t test of Student or the test of Mann and Whitney, according to the shape of the distribution.

    Qualitative secondary outcome will be described in each group by the number/percentage of patients and compared using the chi-2 test or the exact test of Fisher.

Study contacts

Contact information is provided by the study sponsor or research team.

FELLAHI Jean-Luc, M.D., Ph.D.,

CONTACT

[email protected]

(+33) 4 72 11 89 33

SAMSON Géraldine

CONTACT

[email protected]

(+33) 4.27.85.53.26

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery : a Multicenter, Randomized, Controlled Trial (AEGIS Study)

Acronym: AEGIS

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 5, 2023
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.