Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery : a Multicenter, Randomized, Controlled Trial (AEGIS Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 722
- 试验地点
- 10
- 主要终点
- A composite of postoperative complications rate adapted from the Clavien-Dindo classification with only events ≥ class II
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Optimized group managed by the 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.
干预措施: individualized goal-directed fluid therapy by Starling device (Procedure)
Control 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).
干预措施: group managed by standard of care (Procedure)
结局指标
主要结局
A composite of postoperative complications rate adapted from the Clavien-Dindo classification with only events ≥ class II
时间窗: 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
次要结局
- Each item of the primary composite endpoint between both groups(Within 30 days after the surgery)
- Length of stay in hospital (days) and number/percentage of patients with length of stay in hospital ≥ 5 days in each group(5 days)
- APGAR surgical score and number/percentage of patients with APGAR surgical score < 7 in each group(1 day)