Effect of VExUS Score-Guided Intraoperative Goal-Directed Fluid Therapy on Postoperative Pulmonary Complications in Elderly Patients Undergoing McKeown Minimally Invasive Esophagectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 主要终点
- Incidence of postoperative pulmonary complications (PPCs) (%)
研究概览
简要总结
Brief Summary This clinical trial aims to evaluate whether perioperative goal-directed fluid therapy (GDFT) targeting a venous excess ultrasound (VExUS) score of 1 can reduce postoperative pulmonary complications (PPCs) in elderly patients undergoing McKeown minimally invasive esophagectomy (MIE). The study will also assess postoperative organ microcirculatory perfusion and quality of recovery.
Key research questions the trial seeks to answer include:
Does VExUS score-guided GDFT reduce the incidence of PPCs in elderly patients following McKeown MIE? Do participants receiving VExUS-guided GDFT achieve better clinical outcomes? Investigators will compare VExUS score-targeted GDFT with fluid therapy guided by the standard Vigileo-FloTrac™ system, to determine if the VExUS-guided approach reduces the occurrence of postoperative pulmonary complications in elderly patients.
Participant assessments and data collection include:
VExUS score assessment at four time points: preoperatively, after thoracic phase of surgery, after abdominal phase of surgery, and at the end of surgery. Concomitant measurements will include capillary refill time (CRT, in minutes), perfusion index (PI), blood lactate level (Lac, in mmol/L), and central venous oxygen saturation (ScvO₂, in percent).
Postoperative lung ultrasound score assessment. Recording of clinical outcomes including length of intensive care unit (ICU) stay (in days), postoperative hospital length of stay (in days), 30-day postoperative readmission rate due to pulmonary complications (in percent), and in-hospital postoperative mortality rate (in percent).
详细描述
- Background In China, esophageal cancer (EsC) is a common malignancy of the digestive tract, and surgery remains the primary treatment modality . Currently used esophageal tumor resection approaches include McKeown esophagectomy, Ivor Lewis esophagectomy, and Sweet esophagectomy, among others. Among these, thoracoscopic three-incision McKeown minimally invasive esophagectomy (McKeown MIE) offers advantages in lymph node dissection and is therefore one of the commonly used surgical approaches for esophageal cancer. Postoperative pulmonary complications (PPCs) are the most frequent type of complication following esophagectomy, accounting for 28.9%-50% of all complications , and have been demonstrated to be associated with in-hospital mortality , prolonged hospital stay, and increased medical costs .
With the implementation of enhanced recovery after surgery (ERAS) protocols, perioperative fluid management in esophageal cancer surgery has become increasingly important. Inappropriate perioperative fluid volume is an independent risk factor for lung injury . Veelo et al. emphasized that goal-directed hemodynamic therapy can significantly reduce the incidence of postoperative pneumonia . In the absence of continuous hemodynamic monitoring, total intraoperative fluid infusion exceeding 5000 mL should be avoided in patients without ongoing blood loss . Inappropriate intraoperative blood transfusion increases the incidence of PPCs, elevates postoperative mortality, and leads to poorer long-term prognosis due to higher tumor recurrence rates .
Therefore, perioperative fluid management is particularly critical in McKeown MIE. In patients undergoing this procedure, perioperative fluid overload can lead to: (a) increased capillary hydrostatic pressure, and (b) accumulation of excess fluid in the alveolar space, causing alveolar compression, collapse, and exudation, resulting in increased dead space ventilation and intrapulmonary shunt, which in turn induces pulmonary venous congestion and interstitial pulmonary edema. Conversely, inadequate fluid resuscitation may lead to insufficient organ perfusion, exacerbating organ injury such as acute kidney injury (AKI). The traditional "empiric fluid therapy" approach is gradually being replaced by goal-directed fluid therapy (GDFT). Thus, GDFT has become an important target for preventing PPCs in elderly patients undergoing McKeown MIE.
GDFT aims to optimize end-organ perfusion and improve tissue oxygen delivery through precise fluid administration, thereby reducing the risk of PPCs. Existing GDFT strategies include fluid therapy based on dynamic hemodynamic parameters (Vigileo-FloTrac™), central venous pressure (CVP)-guided fluid therapy , perfusion index-guided therapy, and transesophageal echocardiography (TEE)-guided fluid therapy. However, compared with the Venous Excess Ultrasound (VExUS) score, these monitoring modalities cannot accurately and real-time reflect overall venous congestion, nor can they provide integrated monitoring of the matching between venous return driving pressure and right ventricular function.
The VExUS score is an emerging bedside ultrasound-based volume quantification tool that evaluates important capacitance veins, including the inferior vena cava diameter, and the hepatic, portal, and renal veins. By comprehensively monitoring their vessel diameter, resistance indices, and Doppler waveforms, it provides a real-time, non-invasive, and direct reflection of the match between fluid therapy and patient status .
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 80 Years(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 65 and 80 years old
- •Scheduled for elective McKeown MIE
- •ASA physical status classification I to III
- •Body mass index (BMI) between 18 kg/m² and 30 kg/m² (exclusive of 18 kg/m²)
排除标准
- •Respiratory failure (SaO₂ < 60 mmHg and/or PaCO₂ > 50 mmHg)
- •Severe cardiac dysfunction (NYHA class III-IV)
- •Angina pectoris within the past 3 months or acute myocardial infarction (STEMI/NSTEMI) within the past 6 months
- •Pulmonary hypertension (pulmonary artery systolic pressure, PASP > 35 mmHg)
- •Moderate to severe tricuspid stenosis/regurgitation (valve orifice area < 1.5 cm² / vena contracta width ≥ 0.3 cm)
- •Decompensated cirrhosis (Child-Pugh class ≥ B)
- •Chronic kidney disease (CKD stage ≥ 3a) (estimated glomerular filtration rate, eGFR < 45 mL/min/1.73 m²)
- •Cognitive impairment (Mini-Mental State Examination, MMSE < 27) and inability to cooperate with follow-up
结局指标
主要结局
Incidence of postoperative pulmonary complications (PPCs) (%)
时间窗: Censoring will be performed at 30 days, with time to event defined as the time from surgery to ICU admission and discharge. Patients who die in the ICU or before discharge will be censored as not discharged at 30 days.
次要结局
- Postoperative Lung Ultrasound Score (LUS)(points)(Lung ultrasound score assessed at 1 hour postoperatively)
- Duration of Mechanical Ventilation(From time of surgery completion to tracheal extubation, assessed up to 72 hours postoperatively)
- Duration of Non-Invasive Ventilation / High-Flow Nasal Cannula Use(From time of surgery completion to discontinuation of NIV or HFNC support, assessed up to 72 hours postoperatively)
- Oxygenation Index (PaO₂/FiO₂)(PaO₂/FiO₂ ratio)(Oxygenation index measured at three time points: at the end of surgery, at extubation, and 24 hours postoperatively)
- Capillary Refill Time (CRT)(Baseline (preoperatively), immediately after thoracic manipulation, immediately after abdominal manipulation, and at surgery completion (skin closure))
- Peripheral Perfusion Index (PI)(%)(Baseline (preoperatively), immediately after thoracic manipulation, immediately after abdominal manipulation, and at surgery completion (skin closure))
- Lactic Acid (Lac)(mmol/L)(Baseline (preoperatively), immediately after thoracic manipulation, immediately after abdominal manipulation, and at surgery completion (skin closure))
- Central Venous Oxygen Saturation (ScvO₂)(%)(Baseline (preoperatively), immediately after thoracic manipulation, immediately after abdominal manipulation, and at surgery completion (skin closure))
- Length of ICU Stay(From time of surgery completion to ICU discharge, assessed up to 30 days postoperatively)
- Length of Postoperative Hospital Stay(days)(From time of surgery completion to hospital discharge, assessed up to 30 days postoperatively)
- 30-Day Readmission Rate Due to Pulmonary Complications(%)(Proportion of patients readmitted to hospital within 30 days due to pulmonary complications)
- In-Hospital Postoperative Mortality(From time of surgery completion to hospital discharge, assessed up to 30 days postoperatively)
研究者
Mengning Wan
Principal Investigator
First Affiliated Hospital of Chongqing Medical University
