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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Wannan Medical College

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Diagnosis of end-stage renal disease receiving maintenance hemodialysis.

Documented AVG thrombosis requiring PTA.

Able to cooperate and tolerate EIT monitoring.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Observation Cohort1 intervention

Trial outcomes

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.

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

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

Ratio of physiologic dead space to tidal volume, calculated by EIT validated algorithm, reflecting inefficiency of ventilation.

Time frame
Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
3

Change in Intrapulmonary Shunt Fraction

Percentage of the lung region showing perfusion without ventilation, estimated from EIT perfusion signals.

Time frame
Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
4

Change in Regional Ventilation and Perfusion Distribution

Variation in spatial patterns of pulmonary ventilation and perfusion derived from pixel-based EIT data.

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

Other outcomes

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