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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07613632
Enrollment
20
Registered
2026-05-29
Start date
2024-10-24
Completion date
2027-12-30
Last updated
2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

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.

Interventions

DIAGNOSTIC_TESTElectrical 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.

Sponsors

First Affiliated Hospital of Wannan Medical College
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Ventilation-Perfusion Matching IndexBaseline (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

MeasureTime frameDescription
Change in Peripheral Oxygen SaturationBaseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
Change in Physiological Dead Space FractionBaseline (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.
Change in Intrapulmonary Shunt FractionBaseline (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.
Change in Regional Ventilation and Perfusion DistributionBaseline (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.

Countries

China

Contacts

CONTACTqiancheng xu, PhD
qianchengxu@wnmc.edu.cn+86-18297529106

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026