NCT06566456

Effect of Modified Radial Artery Cannulation Site on IABP Monitoring Stability

The Impact of Modified Site for Radial Artery Cannulation on the Stability of Arterial Blood Pressure Monitoring

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 486 (actual)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Invasive arterial blood pressure (IABP) monitoring is critical for perioperative and critically ill patients, yet traditional radial artery cannulation near the wrist joint is prone to catheter dysfunction (e.g., kinking, occlusion) due to positional changes, compromising accuracy and patient safety. This trial hypothesizes that modifying the cannulation site to 1.5-2.5 cm proximal to the radial styloid process may enhance catheter stability.

Detailed description

Methods and analysis:This is a prospective, parallel-group, randomized, controlled, analyst-blinded trial. A total of 486 participants (231 per group, adjusted for 5% dropout) will be enrolled. Eligible patients (18-75 years, ASA physical status I-III, requiring elective surgery with radial artery cannulation) will be randomized 1:1 to the modified group (1.5-2.5 cm proximal to the radial styloid process) or the conventional group (traditional site). The primary outcome is the incidence of arterial catheter dysfunction (defined by criteria such as blood sampling difficulty, position-dependent waveform, or improved waveform post-square wave test). Secondary outcomes include frequency of catheter dysfunction, damping abnormality rate, first-puncture success rate, number of arterial punctures,arterial cannulation time, complication incidence, and blood pressure measurement differences. Sample size calculation:This trial utilized a superiority test for sample size calculation. In the 100-case preliminary experiment results, the incidence rate of abnormal arterial catheter function was 30% in the control group and 12% in the modified group. With a predefined superiority margin Δ of -6% (actual observed Δ of -18%), using a type I error rate (α) of 0.025 and statistical power (1-β) of 0.90, statistical calculations determined that 231 participants per group (totaling 462) would be required to detect this difference in a two-sided test. Considering a 5% dropout rate among study subjects, the final planned sample size was adjusted to 486 cases.

Conditions

• Perioperative Arterial Pressure Monitoring

Interventions

Type	Name	Description
PROCEDURE	The puncture site is 1.5-2.5 cm proximal to the radial styloid process	The ultrasound-guided radial artery puncture site is1.5-2.5 cm proximal to the radial styloid process
PROCEDURE	traditional site	The ultrasound-guided radial artery puncture site is level with the radial styloid process and where the radial artery pulse is most prominent

Timeline

• Start date: 2025-09-15
• Primary completion: 2025-09-15
• Completion: 2025-11-27
• First posted: 2024-08-22
• Last updated: 2026-03-17

Locations

1 site across 1 country: China