Ultrasound-guided Femoral Vein Accessibility, Safety and Time for Atrial Fibrillation Treatment (ULTRA-FAST)
Ultrasound-guided or Anatomical Femoral Venipuncture for Pulmonary Vein Isolation for Atrial Fibrillation Treatment
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
The number of pulmonary vein isolation (PVI) therapy for atrial fibrillation (AF) is increasing. Multiple femoral vein cannulation is mandatory for this procedure. There are mainly two methods to cannulate the femoral vein; by anatomical landmark or by under real-time ultrasound-guided. As high anticoagulant level is required for the procedure, there are 0-13% of vascular access complication.
Real-time ultrasound assistance for central venous catheter cannulation has been proven to reduce complications. In the field of AF treatment, multiple femoral vein cannulation is required as many catheter is required for the procedure and larger sheaths are inserted with a high anticoagulant level during the procedure. In this setting, the use of ultrasound use is not well studied.
The current study is to confirm whether real time ultrasound-guided femoral vein cannulation for PVI can prevent complications, reduce puncture time, puncture attempts and accidental artery puncture compared to conventional anatomical approach. Two seethes for each femoral vein is going to be cannulated.
The study design is a multicenter prospective randomized trial to compare the above safety and efficacy by using the ultrasound-guided and anatomical landmark approach. Also time for cannulation, number of puncture attempts, need of X-ray for cannulation will be analyzed in the setting of patient factors including age, body mass index and sex.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patients undergoing pulmonary vein isolation with radiofrequency catheter ablation for atrial fibrillation treatment.
Exclusion Criteria:
- Patients with prior known vascular access problems or priory included to the current study.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Real-time ultrasound-guided puncture
Cannulate each femoral veins with two wires with real-time ultrasound-guided method.
|
A 7 megahertz ultrasound linear probe will be used.
|
|
Annen: Anatomical landmark guided puncture
Cannulate each femoral veins with two wires with the anatomical landmark guided method.
|
Anatomical landmark puncture
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Major complications
Tidsramme: After the puncture up to 12 weeks
|
Total patient number of vascular complications requiring surgical treatment, retroperitoneal hematoma requiring blood transfusion or hemoglobin drop of 3 >g/dl, strong pain at the groin, prolonging hospital stay and requiring hospital admission after discharge.
|
After the puncture up to 12 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Unsuccessful femoral vein cannulation
Tidsramme: Immediately after the puncture
|
Number of patients with unsuccessful femoral vein cannulation defined as crossing over to the other randomized method or change of operator to cannulate all wires.
|
Immediately after the puncture
|
|
Number of puncture attempts
Tidsramme: Immediately after the puncture
|
Number of puncture attempts to cannulate all wires.
|
Immediately after the puncture
|
|
Total puncture time
Tidsramme: Immediately after the puncture
|
Time from giving anesthesia to the groin till confirming all wires in the infra vena cava with the X-ray.
|
Immediately after the puncture
|
|
Number of artery mis-punctures
Tidsramme: Immediately after the puncture
|
Number of artery mis-punctures attempts to cannulate all wires.
|
Immediately after the puncture
|
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Use of X-ray for successful wire cannulation
Tidsramme: Immediately after the puncture
|
If there is a need of X-ray to cannulate the wire into the infra vena cava.
|
Immediately after the puncture
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Joseph Kautzner, MD, PhD, Institute for Clinical and Experimental Medicine
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ULTRA-FAST
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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