Impact of Non-invasive Individualized Goal-directed Fluid Therapy on Outcomes Following Thoracic Cancer Surgery
- Conditions
- High-risk Lung Resection Surgery
- Interventions
- Device: individualized goal-directed fluid therapy by Starling deviceDevice: group managed by standard of care
- Registration Number
- NCT06156943
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
High-risk patients scheduled for thoracic cancer 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. To know if chest bioreactance could be used to conduct perioperative GDFT and impact patients 'outcome remains however to be demonstrated.
Indeed, the routine fluid management in patients undergoing thoracic cancer surgery could be responsible of hypovolemia/hypoperfusion and/or hypervolemia/congestion leading to postoperative complications and poor outcomes.
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 thoracic cancer 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 722
- Adults (≥ 18 years old)
- High-risk patients (ASA score ≥ 3 and/or ventilatory deficit ≥ 30% and/or AKI risk index ≥ III (9) and/or RCRI > 2) undergoing elective open-chest or video-assisted thoracic cancer surgery
- Patients who have provided written informed consent to participate in the study
- Patients affiliated with a social health insurance
- Elective thoracic surgery other than cancer
- Emergency surgery (< 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 highly effective methods of contraception
- Female patients with positive β-HCG blood test
- Patients under judicial protection (guardianship, curatorship)
- Patients undergoing psychiatric treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Optimized group managed by the Starling device individualized goal-directed fluid therapy by Starling device In the optimized group, patients will be managed intraoperatively with the Starling device according to the Société Française d'Anesthésie Réanimation 2024 GDFT protocol (Alter C. https://sfar.org/optimisation-hemodynamique-perioperatoire-adulte-dont-obstetrique/). It is a non-invasive fluid management monitoring system provides continuous hemodynamic monitoring and empowers fluid management across the continuum of care. Thanks to this device, patients will be managed according to the following protocol: fluid responsiveness will be systematically assessed after anesthetic induction and throughout the procedure as soon as the basal SV monitored by the Starling device decrease by at least 10%. To do so, repetitive fluid challenges (200 ± 50 ml of cristalloids) will be quickly delivered until SV stops to increase by 10% or more. Vasoactive and/or inotropic agents will be used at the discretion of the attending anesthesiologists in case of fluid unresponsiveness. Control group managed by standard of care group managed by standard of care In the control group, patients will be managed intraoperatively at the discretion of the attending anesthesiologists, in accordance with their institutional protocols (i.e. fluids and/or vasoactive agents are given to maintain mean arterial pressure ≥ 65 mmHg).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Each item of the primary composite endpoint between both groups 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.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.
Trial Locations
- Locations (10)
Hopital Louis Pradel
🇫🇷Bron, France
CHU Dijon Bourgogne
🇫🇷Dijon, France
Hôpital Arnaud de Villeneuve - CHU Montpellier
🇫🇷Montpellier, France
Chu Nancy
🇫🇷Nancy, France
Hôpital Européen Georges Pompidou
🇫🇷Paris, France
Hopital du Haut-Leveque - CHU Bordeaux
🇫🇷Pessac, France
CHU de Rennes
🇫🇷Rennes, France
CHU Nantes
🇫🇷Saint-Herblain, France
CHU Strasbourg
🇫🇷Strasbourg, France
Chu Toulouse
🇫🇷Toulouse, France