Changes in Regional Ventilation-Perfusion Match Following Percutaneous Transluminal Angioplasty for Arteriovenous Graft Thrombosis

NCT07613632 | Recruiting

• 1 other identifier: 2026-ICU04
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with end-stage renal disease (ESRD) often require arteriovenous grafts (AVG) for hemodialysis. AVG thrombosis is a common complication, usually managed by percutaneous transluminal angioplasty (PTA) to restore blood flow. PTA achieves patency by balloon-mediated compression and fragmentation of thrombus. Small thrombus fragments may enter the venous circulation and cause transient pulmonary microembolism, leading to ventilation-perfusion (V/Q) mismatch. This study uses electrical impedance tomography (EIT) to noninvasively monitor short-term changes in regional ventilation and perfusion during and after PTA, exploring the immediate pulmonary physiological consequences of thrombus fragmentation and revascularization in dialysis patients.

Conditions

Arteriovenous Graft Thrombosis; End Stage Renal Disease on Dialysis

Keywords

Percutaneous Transluminal Angioplasty; Electrical Impedance Tomography; Ventilation-Perfusion Matching; Pulmonary Microembolism; Dead Space; Shunt; Pilot Study

Outcome Measures

Primary Outcomes (1)

• Change in Ventilation-Perfusion Matching Index

  Quantitative index derived from EIT ventilation and perfusion maps, indicating spatial regional correlation of air and blood flow distribution.

  Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.

Secondary Outcomes (4)

• Change in Peripheral Oxygen Saturation

  Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.

• Change in Physiological Dead Space Fraction

  Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.

• Change in Intrapulmonary Shunt Fraction

  Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.

• Change in Regional Ventilation and Perfusion Distribution

  Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.

Study Arms (1)

Observation Cohort

All enrolled patients will undergo clinically indicated PTA under standard care. EIT monitoring will be performed continuously before, during, and after recanalization to record regional ventilation and perfusion data. No experimental drug or device will be administered beyond routine care.

Diagnostic Test: Electrical Impedance Tomography (EIT) Monitoring

Interventions

Electrical Impedance Tomography (EIT) Monitoring DIAGNOSTIC_TEST

Non-invasive 16-electrode EIT belt applied at the 4th intercostal level. Continuous data acquisition begins 10 min pre-PTA, continues throughout balloon angioplasty, and up to 30 min post-recanalization. No alteration to standard clinical care.

Observation Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with end-stage renal disease (ESRD) undergoing maintenance hemodialysis who present with thrombosed arteriovenous grafts (AVG) requiring clinically indicated percutaneous transluminal angioplasty (PTA) to restore patency. The study population will consist of adult patients (18-80 years) admitted to the interventional radiology or dialysis access unit of the First Affiliated Hospital of Wannan Medical College (Yijishan Hospital). All participants will receive routine PTA treatment as part of standard care. EIT monitoring will be applied non-invasively to collect ventilation and perfusion signals before and after PTA. No additional interventions beyond routine clinical management will be introduced.

You may qualify if:

• Age ≥ 18 years.
• Diagnosis of end-stage renal disease receiving maintenance hemodialysis.
• Documented AVG thrombosis requiring PTA.
• Able to cooperate and tolerate EIT monitoring.
• Provided written informed consent.

You may not qualify if:

• Severe respiratory failure incompatible with supine position.
• Thoracic skin condition or deformity preventing EIT electrode placement.
• Acute pulmonary embolism or acute pulmonary edema before procedure.
• NYHA Class IV heart failure or hemodynamic instability.
• Pregnancy or breastfeeding.
• Any other circumstance judged unsuitable by investigator.

Sponsors & Collaborators

• First Affiliated Hospital of Wannan Medical College: lead

Study Sites (1)

The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)

Wuhu, China

RECRUITING

Central Study Contacts

qiancheng xu, PhD

CONTACT

+86-18297529106; qianchengxu@wnmc.edu.cn

Study Design

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

Study Record Dates

• First Submitted: May 23, 2026
• First Posted: May 29, 2026
• Study Start: October 24, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

CN (1)