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- Essai clinique NCT06077396
La canulation de l'artère radiale affecte-t-elle l'indice de perfusion (IP) de la main lors des opérations de transplantation hépatique ? (radial artery)
La canulation de l'artère radiale affecte-t-elle l'indice de perfusion de la main lors d'une transplantation hépatique ?
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
## 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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: duygu demiroz
- Numéro de téléphone: 905319504421
- E-mail: drduygudemiroz@hotmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: 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. |
|
Autre: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Perfusion Index from Baseline Following Radial Artery Catheterization
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
First-Attempt Radial Artery Catheterization Success Rate
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: duygu demiröz, INONU UNİVERSİTY
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- INU-LT-RAC-2026-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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