Changes in Regional Ventilation-Perfusion Match Following Percutaneous Transluminal Angioplasty for Arteriovenous Graft Thrombosis
23 maj 2026 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Beräknad)
20
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: qiancheng xu, PhD
- Telefonnummer: +86-18297529106
- E-post: qianchengxu@wnmc.edu.cn
Studieorter
-
-
-
Wuhu, Kina
- Rekrytering
- The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
-
Kontakt:
- Shengsheng xu
- Telefonnummer: 86-18315329399
- E-post: taoshengsheng@yjsyy.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Ventilation-Perfusion Matching Index
Tidsram: Baseline (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.
|
Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Peripheral Oxygen Saturation
Tidsram: Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
|
Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
|
|
|
Change in Physiological Dead Space Fraction
Tidsram: Baseline (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.
|
Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
|
|
Change in Intrapulmonary Shunt Fraction
Tidsram: Baseline (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.
|
Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
|
|
Change in Regional Ventilation and Perfusion Distribution
Tidsram: Baseline (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.
|
Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
24 oktober 2024
Primärt slutförande (Beräknad)
30 september 2027
Avslutad studie (Beräknad)
30 december 2027
Studieregistreringsdatum
Först inskickad
23 maj 2026
Först inskickad som uppfyllde QC-kriterierna
23 maj 2026
Första postat (Faktisk)
29 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 2026-ICU04
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .