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
This trial does not accept healthy volunteersQualifiers
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 population
The study protocol has been submitted for ethical approval to the Ethics Committee of the First Affiliated Hospital of Chongqing Medical University. A total of 126 patients scheduled for elective thoracoscopic three-incision radical esophagectomy (McKeown MIE) will be recruited from the Department of Anesthesiology, First Affiliated Hospital of Chongqing Medical University between February 2026 and July 2026.
Trial design
Case-control
Prospective
Treatments tested in this trial
VExUS Score-Guided Intraoperative Goal-Directed Fluid Therapy
Procedure/SurgeryIntervention Group: VExUS score will be performed by an ultrasonographer proficient in ultrasound operation (with \> 100 cases of experience and special certification from the Ultrasound Physician Branch of the Chinese Medical Doctor Association) at the following time points: preoperatively, after thoracic procedure, after abdominal procedure, and at the end of surgery.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of postoperative pulmonary complications (PPCs) (%)
Secondary outcomes
Postoperative Lung Ultrasound Score (LUS)(points)
Duration of Mechanical Ventilation
Time from surgery completion to tracheal extubation (in minutes)
Duration of Non-Invasive Ventilation / High-Flow Nasal Cannula Use
Total duration of NIV or HFNC support in minutes, from surgery completion to discontinuation
Oxygenation Index (PaO₂/FiO₂)(PaO₂/FiO₂ ratio)
Locations
Sponsors and contacts
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