High-risk Lung Resection Surgery
Conditions
Keywords
goal-directed fluid therapy, Chest bioreactance, lung resection surgery
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.
Interventions
PROCEDUREindividualized goal-directed fluid therapy by Starling device
For patients in optimized group, fluids will be managed by Starling device during the lung resection surgery.
PROCEDUREgroup managed by standard of care
Patients will be managed intraoperatively at the discretion of the attending anesthesiologists, in accordance with their institutional protocols
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
The patients are the only ones masked. As double blind is not possible, an adjudication committee, whose members will be unaware of the procedure assignments, will adjudicate all the clinical outcomes.
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A composite of postoperative complications rate adapted from the Clavien-Dindo classification with only events ≥ class II | 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
| Measure | Time frame | Description |
|---|---|---|
| Each item of the primary composite endpoint between both groups | 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. |
| Length of stay in hospital (days) and number/percentage of patients with length of stay in hospital ≥ 5 days in each group | 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. |
| APGAR surgical score and number/percentage of patients with APGAR surgical score < 7 in each group | 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. |
Countries
France
Contacts
Primary ContactFELLAHI Jean-Luc, M.D., Ph.D.,
Backup ContactSAMSON Géraldine
Outcome results
None listed