Clinical trial · Observational
Effect of VExUS Score on Postoperative Pulmonary Complications in Elderly Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer (EsC) | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.85 |
| Postoperative Pulmonary Complications (PPCs) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VExUS Score-Guided Intraoperative Goal-Directed Fluid Therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of postoperative pulmonary complications (PPCs) (%)
- timeFrame
- 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.
Secondary outcomes (12)
- measure
- Postoperative Lung Ultrasound Score (LUS)（points）
- timeFrame
- Lung ultrasound score assessed at 1 hour postoperatively
- measure
- Duration of Mechanical Ventilation
- timeFrame
- From time of surgery completion to tracheal extubation, assessed up to 72 hours postoperatively
- description
- Time from surgery completion to tracheal extubation (in minutes)
- measure
- Duration of Non-Invasive Ventilation / High-Flow Nasal Cannula Use
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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) Exclusion Criteria: * 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
References
Publications (27)
- BACKGROUNDZhang YT, Chen Y, Shang KX, Yu H, Li XF, Yu H. Effect of Volatile Anesthesia Versus Intravenous Anesthesia on Postoperative Pulmonary Complications in Patients Undergoing Minimally Invasive Esophagectomy: A Randomized Clinical Trial. Anesth Analg. 2024 Sep 1;139(3):571-580. doi: 10.1213/ANE.0000000000006814. Epub 2024 Feb 9. PMID 38195081
- BACKGROUNDNishio Y, Hara M, Oshita K, Jotaki S, Murotani K, Hiraki T. Relationship between Tryptase and Hypotension in Anaphylaxis during Anesthesia. Kurume Med J. 2024 Jul 2;70(1.2):19-27. doi: 10.2739/kurumemedj.MS7012012. Epub 2024 May 17. PMID 38763736
- BACKGROUNDWang D, Zhang Y, Wang S, Xue Y, Hu X, Gao J, Yu R, Zhuang Q, Cheng E, Li X. Correlation of lung ultrasound score with postoperative pulmonary complications in older adults undergoing thoracoscopic lobectomy: a prospective observational study. Eur J Med Res. 2025 Oct 21;30(1):999. doi: 10.1186/s40001-025-03271-2. PMID 41121392
- BACKGROUNDKroenke K, Lawrence VA, Theroux JF, Tuley MR. Operative risk in patients with severe obstructive pulmonary disease. Arch Intern Med. 1992 May;152(5):967-71. PMID 1580723
- BACKGROUNDCheong I. Unconventional Echocardiographic Techniques for LVOT VTI Measurement in Critical Care Settings. J Clin Ultrasound. 2025 Jul-Aug;53(6):1418-1424. doi: 10.1002/jcu.24007. Epub 2025 Apr 12. PMID 40219729
- BACKGROUNDOba Y, Salzman GA. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury. N Engl J Med. 2000 Sep 14;343(11):813; author reply 813-4. No abstract available. PMID 10991706
- BACKGROUNDZhang Y, Zhan L, Li D, Huang G, Lan Y. Influence of goal-directed fluid therapy guided by the Vigileo-FloTracTM system on intestinal mucosal barrier function in elderly patients with colorectal cancer. Wideochir Inne Tech Maloinwazyjne. 2023 Sep;18(3):460-466. doi: 10.5114/wiitm.2023.128010. Epub 2023 Sep 1.