Ultrasound-guided distal versus conventional radial artery catheterization in older surgical patients: protocol for a randomized controlled noninferiority trial
Year: 2026
Type: article
Study design: Study Protocol
Abstract: Background: Invasive radial arterial monitoring is frequently required in older surgical patients, but age-related vascular changes can make catheterization difficult. Distal radial access may improve catheter stability during wrist movement, shorten hemostasis, and preserve the conventional forearm segment; however, its smaller caliber may reduce technical success. This trial will determine whether ultrasound-guided distal radial artery catheterization is noninferior to conventional radial artery catheterization for first-attempt success in patients aged 65 years or older. Materials and methods: This single-center, parallel-group, randomized noninferiority trial will enroll 198 surgical patients aged 65 years or older who require invasive arterial pressure monitoring. Participants will be allocated 1:1 to distal or conventional radial artery catheterization. Both groups will receive the same real-time ultrasound-guided dynamic needle-tip positioning technique and a 20G*45 mm catheter; only the access site and limb position will differ. The operator cannot be masked, whereas postoperative outcome assessors and the statistician will be masked where feasible. The primary outcome is first-attempt success, defined as catheter placement with free aspiration and an undamped arterial waveform after one skin puncture. Secondary outcomes are overall assigned-site success, procedural efficiency, intraoperative catheter performance, access-site safety and hemostasis, and Doppler-confirmed arterial patency. Noninferiority will be concluded if the lower limit of the two-sided 95% confidence interval for the risk difference (distal minus conventional) is greater than -15 percentage points in both the intention-to-treat (ITT) and per-protocol (PP) populations. Ethics and dissemination: The protocol was prepared in accordance with SPIRIT 2025. This research protocol was approved by the Ethics Committee of Ningbo No. 6 Hospital on 12th March 2026 (Approval No.: 2026-10L), and written informed consent will be obtained before randomization. Results will be disseminated through peer-reviewed publications and scientific presentations. De-identified data and analysis code will be shared after publication, subject to ethics approval and privacy requirements. Clinical Trial Registration: www.chictr.org.cn; identifier ChiCTR2600124338.
Source: Frontiers in Medicine
Institution: Ningbo No.6 Hospital
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,801
OpenAlex ID: W7222918106