Changes in Regional Ventilation-Perfusion Match Following Percutaneous Transluminal Angioplasty for Arteriovenous Graft Thrombosis
23. mai 2026 oppdatert av: Qiancheng Xu, First Affiliated Hospital of Wannan Medical College
Changes in Regional Ventilation-Perfusion Match Following Percutaneous Transluminal Angioplasty for Arteriovenous Graft Thrombosis: A Prospective Observation Pilot Study
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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Antatt)
20
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: qiancheng xu, PhD
- Telefonnummer: +86-18297529106
- E-post: qianchengxu@wnmc.edu.cn
Studiesteder
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Wuhu, Kina
- Rekruttering
- The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
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Ta kontakt med:
- Shengsheng xu
- Telefonnummer: 86-18315329399
- E-post: taoshengsheng@yjsyy.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Observation Cohort
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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Ventilation-Perfusion Matching Index
Tidsramme: Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
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Quantitative index derived from EIT ventilation and perfusion maps, indicating spatial regional correlation of air and blood flow distribution.
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Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Peripheral Oxygen Saturation
Tidsramme: Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
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Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
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Change in Physiological Dead Space Fraction
Tidsramme: Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
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Ratio of physiologic dead space to tidal volume, calculated by EIT validated algorithm, reflecting inefficiency of ventilation.
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Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
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Change in Intrapulmonary Shunt Fraction
Tidsramme: Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
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Percentage of the lung region showing perfusion without ventilation, estimated from EIT perfusion signals.
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Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
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Change in Regional Ventilation and Perfusion Distribution
Tidsramme: Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
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Variation in spatial patterns of pulmonary ventilation and perfusion derived from pixel-based EIT data.
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Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
24. oktober 2024
Primær fullføring (Antatt)
30. september 2027
Studiet fullført (Antatt)
30. desember 2027
Datoer for studieregistrering
Først innsendt
23. mai 2026
Først innsendt som oppfylte QC-kriteriene
23. mai 2026
Først lagt ut (Faktiske)
29. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 2026-ICU04
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