About this trial
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).
Eligibility criteria
Qualifiers
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- VExUS Score-Guided Intraoperative Goal-Directed Fluid Therapy