Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07613632

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Wuhu, China

Location status: Recruiting

Location contact

Shengsheng xu

CONTACT

[email protected]

86-18315329399

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Peripheral Oxygen Saturation

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

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

qiancheng xu, PhD

CONTACT

[email protected]

+86-18297529106

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Wannan Medical College

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.