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临床试验/NCT07613632
NCT07613632招募中不适用

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

First Affiliated Hospital of Wannan Medical College1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年10月24日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究者

发起方
First Affiliated Hospital of Wannan Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Qiancheng Xu

Principal Investigator

First Affiliated Hospital of Wannan Medical College

研究点 (1)

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