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July. 10, 2026 |
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July. 10, 2026 |
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jRCT1030260292 |
Efficacy of Preoperative Ultrasound Assessment of the Radial Artery for Determining the Arterial Cannulation |
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Efficacy of Preoperative Ultrasound Assessment of the Radial Artery for Determining the Arterial Cannulation (Efficacy of Ultrasound Assessment for the Radial Artery Cannulation) |
Ueda Kenichi |
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Kameda Medical Center |
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929 Higashimachi, Kamogawashi, Chiba, Japan |
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+81-4-7092-2211 |
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ueda.kenichi@kameda.jp |
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Ueda Kenichi |
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Kameda Medical Center |
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929 Higashimachi, Kamogawashi, Chiba, Japan |
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+81-4-7092-2211 |
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kyamashita508@gmail.com |
Recruiting |
July. 10, 2026 |
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| 500 | ||
Interventional |
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randomized controlled trial |
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single blind |
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no treatment control/standard of care control |
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parallel assignment |
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other |
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1. Adult patients scheduled to undergo elective surgery under general anesthesia at our institution, for whom radial arterial line placement is planned for invasive blood pressure monitoring during surgery |
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1. Patients judged unable to provide sufficient cooperation for preoperative ultrasonographic examination due to impaired consciousness, cognitive decline, delirium, or severe agitation |
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| 18age old over | ||
| No limit | ||
Both |
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Adult patients scheduled to undergo elective surgery under general anesthesia |
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Preoperative ultrasonographic assessment of the radial artery will be performed at the preoperative outpatient visit or on the day of surgery using an ultrasound device (V scan, GE Healthcare, USA). The radial artery will be evaluated with a high-frequency linear probe in both short-axis and long-axis views, and the following parameters will be measured and assessed. The region of interest will be defined as the distal one-third of the segment between the elbow joint and the proximal wrist crease. |
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Radial artery, General anesthesia |
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Ultrasonography, Catheterization Peripheral, Ultrasonography nterventional, Radial Artery |
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D014463, D002406, D018084, D017534 |
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For the primary outcome, a superiority test will first be performed to assess the difference in time to successful puncture between the palpation group and the ultrasound-guided group. If no statistically significant difference is observed between the two groups, a non-inferiority analysis will be conducted to determine whether the palpation method is non-inferior to the ultrasound-guided method within a clinically acceptable margin. The non-inferiority margin will be set at 30 seconds based on prior studies and clinical plausibility, and non-inferiority will be considered demonstrated if the upper limit of the 95% confidence interval for the between-group difference (palpation method minus ultrasound-guided method) lies below this margin. The primary analysis will be based on the intention-to-treat principle, with a per-protocol analysis performed as a supplementary analysis where necessary. |
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For secondary outcomes, the following will be recorded and compared between groups: first-attempt success rate, success rate within 5 minutes, number of puncture attempts (defined as one attempt each time the needle is fully withdrawn), need for reinsertion during surgery, rate of conversion to non-invasive blood pressure monitoring, and the occurrence of complications (e.g., hematoma formation, radial nerve injury). |
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| Kameda medical center clinical research ethics committee | |
| 929 Higashimachi, Kamogawa, Chiba, Japan, Chiba | |
+81-4-7092-2211 |
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| clinical_research@kameda.jp | |
| Approval | |
June. 08, 2026 |
Yes |
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Data will be stored in REDCap. Password-protected OneDrive online storage will be used, with access controls implemented to prevent unauthorized external access. |
none |