- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT06077396
Påverkar radiell artärkanylering perfusionsindex (PI) för handen vid levertransplantationsoperationer? (radial artery)
Påverkar radial artärkanylering perfusionsindexet för handen vid levertransplantation?
This randomized controlled trial compared palpation-guided and ultrasound-guided radial artery catheterization in adult liver transplant recipients. The primary outcome was the change in perfusion index (Pi) from baseline after catheterization. Secondary outcomes included first-attempt success, number of skin punctures, procedure time, overall success with the assigned technique, and local complications.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
## DLiver transplantation is associated with major hemodynamic changes, and continuous invasive arterial pressure monitoring is an essential part of perioperative management. The radial artery is the most commonly used site. Repeated punctures and mechanical trauma during catheterization may cause local complications and affect peripheral perfusion. Ultrasound guidance may facilitate catheter placement with fewer punctures.
The perfusion index (Pi), derived from pulse oximetry, is the ratio of the pulsatile to the non-pulsatile optical signal and is used to monitor peripheral perfusion. Because Pi is also influenced by systemic hemodynamics, sympathetic activity, temperature, nociception and drugs, changes in Pi were not interpreted as direct evidence of radial artery vasospasm.
In this prospective, randomized, controlled, two-arm parallel-group trial, adult liver transplant recipients were randomized 1:1 to palpation-guided or ultrasound-guided radial artery catheterization. Randomization used a computer-generated sequence and sequentially numbered, opaque, sealed envelopes prepared by an independent person. The envelope was opened after induction of general anesthesia, once hemodynamic stability was achieved and immediately before catheterization. All procedures were performed by a single anesthesiologist experienced in both techniques, using the same 20-gauge non-guidewire arterial cannula in both groups, preferably on the non-dominant hand after a normal modified Allen test.
In the ultrasound group, a high-frequency linear probe was used with a short-axis out-of-plane approach and dynamic needle tip positioning. Pi was measured continuously with a pulse oximetry sensor placed on the index finger the hand. Pi, heart rate, SpO2, pleth variability index (PVI), SpHb and SpOC were recorded immediately before catheterization (baseline) and immediately after catheterization; Pi was additionally recorded 5 and 10 minutes after catheterization.
The primary outcome was the change in Pi from baseline over time. The primary analysis used a linear mixed-effects model including group, time and the group-by-time interaction to account for repeated measurements. Secondary outcomes were compared with appropriate tests (t test or Mann-Whitney U test; chi-square or Fisher's exact test). Results were reported with effect estimates and 95% confidence intervals; a two-sided p<0.05 was considered statistically significant.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: duygu demiroz
- Telefonnummer: 905319504421
- E-post: drduygudemiroz@hotmail.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Adult patients (18 years of age or older) undergoing liver transplantation.
- Patients eligible for radial artery catheterization as part of perioperative monitoring.
- Patients who provide informed consent to participate in the study.
Exclusion Criteria:
- Patients in whom radial artery catheterization is contraindicated.
- Patients who do not provide informed consent to participate in the study.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: Conventional Palpation
Conventional Palpation |
Radial artery catheterization was performed after induction of general anesthesia, preferably on the non-dominant hand after a normal modified Allen test. The radial pulse was identified by palpation and the artery was cannulated using anatomical landmarks with a 20-gauge non-guidewire arterial cannula, the same cannula used in the ultrasound group. The procedure was limited to a maximum of three skin punctures. |
|
Övrig: Guided Catheterization
-Radial artery catheterization was performed after induction of general anesthesia using the conventional palpation technique. The radial pulse was identified by palpation and the artery was cannulated using anatomical landmarks with a 20-gauge non-guidewire arterial cannula, limited to a maximum of three skin punctures. |
Radial artery catheterization performed under real-time ultrasound guidance using an integrated guidewire arterial cannula system. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Perfusion Index from Baseline Following Radial Artery Catheterization
Tidsram: Perfusion index (Pi) will be measured at baseline, immediately after radial artery catheterization, and at 5 and 10 minutes after the procedure to evaluate changes in peripheral perfusion.
|
Perfusion index (Pi) will be measured at baseline, immediately after radial artery catheterization, and at 5 and 10 minutes after the procedure to assess changes in peripheral perfusion between the palpation-guided and ultrasound-guided catheterization groups. |
Perfusion index (Pi) will be measured at baseline, immediately after radial artery catheterization, and at 5 and 10 minutes after the procedure to evaluate changes in peripheral perfusion.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
First-Attempt Radial Artery Catheterization Success Rate
Tidsram: During the catheterization procedure
|
The proportion of participants in whom radial artery catheterization is successfully completed on the first skin puncture. |
During the catheterization procedure
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: duygu demiröz, INONU UNİVERSİTY
Publikationer och användbara länkar
Allmänna publikationer
- Brzezinski M, Luisetti T, London MJ. Radial artery cannulation: a comprehensive review of recent anatomic and physiologic investigations. Anesth Analg. 2009 Dec;109(6):1763-81. doi: 10.1213/ANE.0b013e3181bbd416.
- Numaguchi A, Adachi YU, Aoki Y, Ishii Y, Suzuki K, Obata Y, Sato S, Nishiwaki K, Matsuda N. Radial artery cannulation decreases the distal arterial blood flow measured by power Doppler ultrasound. J Clin Monit Comput. 2015 Oct;29(5):653-7. doi: 10.1007/s10877-014-9648-5. Epub 2014 Dec 16.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- INU-LT-RAC-2026-01
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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