Effect of VExUS Score on Postoperative Pulmonary Complications in Elderly Patients

NCT07691944 | Not Yet Recruiting

• 1 other identifier: H50010300166
• Study Type: observational
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Esophageal Cancer (EsC); Postoperative Pulmonary Complications (PPCs)

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative pulmonary complications (PPCs) (%)

  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)

• 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)

Interventions

VExUS Score-Guided Intraoperative Goal-Directed Fluid Therapy PROCEDURE

Intervention 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.

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Related Publications (27)

• Zhang 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 BACKGROUND

• Nishio 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 BACKGROUND

• Wang 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 BACKGROUND

• Kroenke 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 BACKGROUND

• Cheong 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 BACKGROUND

• Oba 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 BACKGROUND

• Zhang 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.

  PMID: 37868288 BACKGROUND

• Yang G, Hu C, Sun Z. An Updated Review of Driving-Pressure Guided Ventilation Strategy and Its Clinical Application. Biomed Res Int. 2022 Aug 2;2022:6236438. doi: 10.1155/2022/6236438. eCollection 2022.

  PMID: 35958824 BACKGROUND

• Park M, Ahn HJ, Kim JA, Yang M, Heo BY, Choi JW, Kim YR, Lee SH, Jeong H, Choi SJ, Song IS. Driving Pressure during Thoracic Surgery: A Randomized Clinical Trial. Anesthesiology. 2019 Mar;130(3):385-393. doi: 10.1097/ALN.0000000000002600.

  PMID: 30664548 BACKGROUND

• Shen Y, Zhong M, Wu W, Wang H, Feng M, Tan L, Wang Q. The impact of tidal volume on pulmonary complications following minimally invasive esophagectomy: a randomized and controlled study. J Thorac Cardiovasc Surg. 2013 Nov;146(5):1267-73; discussion 1273-4. doi: 10.1016/j.jtcvs.2013.06.043. Epub 2013 Aug 28.

  PMID: 23993028 BACKGROUND

• Brogger H. [The new Declaration of Helsinki]. Tidsskr Nor Laegeforen. 2023 Dec 14;143(1). doi: 10.4045/tidsskr.23.0798. Print 2024 Jan 23. No abstract available. Norwegian.

  PMID: 38258726 BACKGROUND

• Song J, Chen G, Lai D, Zhong L, Fan H, Hu W, Wang M, Hu C, Chen W, Ming Z, Gong S, Luo Q. Association between the Venous Excess Ultrasound (VExUS) score and acute kidney injury in critically ill patients with sepsis: a multicenter prospective observational study. Ann Intensive Care. 2025 Jul 23;15(1):105. doi: 10.1186/s13613-025-01529-w.

  PMID: 40699273 BACKGROUND

• Pierre-Gregoire G. VExUS score: optimizing its use in perioperative and critical care management. Crit Care. 2025 Nov 4;29(1):472. doi: 10.1186/s13054-025-05687-y.

  PMID: 41188936 BACKGROUND

• Brat K, Sova M, Homolka P, Plutinsky M, Genzor S, Pokorna A, Dosbaba F, Imrichova B, Chovanec Z, Mitas L, Mikulaskova M, Svoboda M, Olson L, Cundrle I; study group. Multimodal prehabilitation before lung resection surgery: a multicentre randomised controlled trial. Br J Anaesth. 2025 Jul;135(1):188-196. doi: 10.1016/j.bja.2025.03.018. Epub 2025 May 14.

  PMID: 40374400 BACKGROUND

• Reeh M, Ghadban T, Dedow J, Vettorazzi E, Uzunoglu FG, Nentwich M, Kluge S, Izbicki JR, Vashist YK. Allogenic Blood Transfusion is Associated with Poor Perioperative and Long-Term Outcome in Esophageal Cancer. World J Surg. 2017 Jan;41(1):208-215. doi: 10.1007/s00268-016-3730-8.

  PMID: 27730355 BACKGROUND

• Towe CW, Gulack BC, Kim S, Ho VP, Perry Y, Donahue JM, Linden PA. Restrictive Transfusion Practices After Esophagectomy Are Associated With Improved Outcome: A Review of the Society of Thoracic Surgeons General Thoracic Database. Ann Surg. 2018 May;267(5):886-891. doi: 10.1097/SLA.0000000000002231.

  PMID: 28338513 BACKGROUND

• Durkin C, Schisler T, Lohser J. Current trends in anesthesia for esophagectomy. Curr Opin Anaesthesiol. 2017 Feb;30(1):30-35. doi: 10.1097/ACO.0000000000000409.

  PMID: 27764049 BACKGROUND

• Bahlmann H, Halldestam I, Nilsson L. Goal-directed therapy during transthoracic oesophageal resection does not improve outcome: Randomised controlled trial. Eur J Anaesthesiol. 2019 Feb;36(2):153-161. doi: 10.1097/EJA.0000000000000908.

  PMID: 30431499 BACKGROUND

• Kaufmann K, Heinrich S. Minimizing postoperative pulmonary complications in thoracic surgery patients. Curr Opin Anaesthesiol. 2021 Feb 1;34(1):13-19. doi: 10.1097/ACO.0000000000000945.

  PMID: 33315642 BACKGROUND

• Nozaki I, Mizusawa J, Kato K, Igaki H, Ito Y, Daiko H, Yano M, Udagawa H, Nakagawa S, Takagi M, Kitagawa Y. Impact of laparoscopy on the prevention of pulmonary complications after thoracoscopic esophagectomy using data from JCOG0502: a prospective multicenter study. Surg Endosc. 2018 Feb;32(2):651-659. doi: 10.1007/s00464-017-5716-5. Epub 2017 Aug 4.

  PMID: 28779246 BACKGROUND

• Klevebro F, Elliott JA, Slaman A, Vermeulen BD, Kamiya S, Rosman C, Gisbertz SS, Boshier PR, Reynolds JV, Rouvelas I, Hanna GB, van Berge Henegouwen MI, Markar SR. Cardiorespiratory Comorbidity and Postoperative Complications following Esophagectomy: a European Multicenter Cohort Study. Ann Surg Oncol. 2019 Sep;26(9):2864-2873. doi: 10.1245/s10434-019-07478-6. Epub 2019 Jun 10.

  PMID: 31183640 BACKGROUND

• Gottlieb-Vedi E, Kauppila JH, Mattsson F, Hedberg J, Johansson J, Edholm D, Lagergren P, Nilsson M, Lagergren J; FINEGO group. Extent of Lymphadenectomy and Long-term Survival in Esophageal Cancer. Ann Surg. 2023 Mar 1;277(3):429-436. doi: 10.1097/SLA.0000000000005028. Epub 2021 Jun 25.

  PMID: 34183514 BACKGROUND

• Okamura A, Watanabe M, Mine S, Nishida K, Kurogochi T, Imamura Y. Spirometric Lung Age Predicts Postoperative Pneumonia After Esophagectomy. World J Surg. 2016 Oct;40(10):2412-8. doi: 10.1007/s00268-016-3547-5.

  PMID: 27146051 BACKGROUND

• Derogar M, Orsini N, Sadr-Azodi O, Lagergren P. Influence of major postoperative complications on health-related quality of life among long-term survivors of esophageal cancer surgery. J Clin Oncol. 2012 May 10;30(14):1615-9. doi: 10.1200/JCO.2011.40.3568. Epub 2012 Apr 2.

  PMID: 22473157 BACKGROUND

• Seesing MFJ, Kingma BF, Weijs TJ, Ruurda JP, van Hillegersberg R. Reducing pulmonary complications after esophagectomy for cancer. J Thorac Dis. 2019 Apr;11(Suppl 5):S794-S798. doi: 10.21037/jtd.2018.11.75.

  PMID: 31080660 BACKGROUND

• Pennathur A, Gibson MK, Jobe BA, Luketich JD. Oesophageal carcinoma. Lancet. 2013 Feb 2;381(9864):400-12. doi: 10.1016/S0140-6736(12)60643-6.

  PMID: 23374478 BACKGROUND

• Guinan EM, Bennett AE, Doyle SL, O'Neill L, Gannon J, Foley G, Elliott JA, O'Sullivan J, Reynolds JV, Hussey J. Measuring the impact of oesophagectomy on physical functioning and physical activity participation: a prospective study. BMC Cancer. 2019 Jul 12;19(1):682. doi: 10.1186/s12885-019-5888-6.

  PMID: 31299920 RESULT

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Juying Jin

  STUDY DIRECTOR

Central Study Contacts

Lihua Li Peng, Doctor

CONTACT

+86 89011876; plhcqmu@163.com

Mengninng Wan, Doctor

CONTACT

+86 89011876; 1029211312@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 9, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share