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

May 23, 2026 updated by: Qiancheng Xu, First Affiliated Hospital of Wannan Medical College

Changes in Regional Ventilation-Perfusion Match Following Percutaneous Transluminal Angioplasty for Arteriovenous Graft Thrombosis: A Prospective Observation Pilot Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Arteriovenous graft (AVG) thrombosis is a major source of vascular access failure in ESRD. PTA restores patency through balloon dilation and mechanical thrombus compression. Minor embolic debris can reach the pulmonary bed, transiently disturbing perfusion distribution and V/Q matching. Because the pulmonary circulation is sensitive to sudden peripheral hemodynamic shifts, the PTA period provides a unique opportunity to observe lung perfusion response dynamically.

This single-center, prospective, observational pilot study will continuously record regional ventilation and perfusion by EIT at six time points: 10 min before PTA, at recanalization, and 10, 20, 30 min after, and at procedure completion. Measured variables include: V/Q matching index (primary), physiological dead space fraction (Vd/Vt), intrapulmonary shunt fraction, SPO₂/FiO₂ ratio, and hemodynamic data (balloon pressure, recanalization time, blood flow recovery). Results will be analyzed using repeated-measures ANOVA or mixed-effects modeling.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Wuhu, China
        • Recruiting
        • The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria

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

Exclusion Criteria

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Ventilation-Perfusion Matching Index
Time Frame: Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Peripheral Oxygen Saturation
Time Frame: Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
Change in Physiological Dead Space Fraction
Time Frame: Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
Ratio of physiologic dead space to tidal volume, calculated by EIT validated algorithm, reflecting inefficiency of ventilation.
Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
Change in Intrapulmonary Shunt Fraction
Time Frame: Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
Percentage of the lung region showing perfusion without ventilation, estimated from EIT perfusion signals.
Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
Change in Regional Ventilation and Perfusion Distribution
Time Frame: Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
Variation in spatial patterns of pulmonary ventilation and perfusion derived from pixel-based EIT data.
Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Wannan Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2024

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

May 23, 2026

First Submitted That Met QC Criteria

May 23, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 23, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2026-ICU04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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