Changes in Regional Ventilation-Perfusion Match Following Percutaneous Transluminal Angioplasty for Arteriovenous Graft Thrombosis: A Prospective Observation Pilot Study
| Registry | NCT07613632 |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 20 (Estimated) |
| Sponsor | First Affiliated Hospital of Wannan Medical College (Other) |
| Conditions | Arteriovenous Graft Thrombosis, End Stage Renal Disease on Dialysis |
| Interventions | Electrical Impedance Tomography (EIT) Monitoring (Diagnostic test) |
| Dates | start 2024-10-24, primary completion 2027-09-30 (estimated), completion 2027-12-30 (estimated), first posted 2026-05-29, last updated 2026-05-29 |
| Locations | 1 site in China |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Observation Cohort | Diagnostic Test: Electrical Impedance Tomography (EIT) Monitoring | 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. |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College) | Wuhu | China | Recruiting |