Effect of VExUS Score on Postoperative Pulmonary Complications in Elderly Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65-80
SponsorFirst Affiliated Hospital of Chongqing Medical University

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 volunteers

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 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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • VExUS Score-Guided Intraoperative Goal-Directed Fluid Therapy

    Procedure/Surgery

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Incidence of postoperative pulmonary complications (PPCs) (%)

Time frame
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

1

Postoperative Lung Ultrasound Score (LUS)(points)

Time frame
Lung ultrasound score assessed at 1 hour postoperatively
2

Duration of Mechanical Ventilation

Time from surgery completion to tracheal extubation (in minutes)

Time frame
From time of surgery completion to tracheal extubation, assessed up to 72 hours postoperatively
3

Duration of Non-Invasive Ventilation / High-Flow Nasal Cannula Use

Total duration of NIV or HFNC support in minutes, from surgery completion to discontinuation

Time frame
From time of surgery completion to discontinuation of NIV or HFNC support, assessed up to 72 hours postoperatively
4

Oxygenation Index (PaO₂/FiO₂)(PaO₂/FiO₂ ratio)

Time frame
Oxygenation index measured at three time points: at the end of surgery, at extubation, and 24 hours postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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