Randomized controlled trial for comparison of the hand dysfunction in coronary diagnosis and intervention via distal vs conventional radial access
Coronary diagnosis and intervention via distal radial access has gradually become an alternative access to the conventional radial access because of its advantages of reducing radial artery occlusion (RAO), shortening compression time, and decreasing patient discomfort. However, as awareness of distal radial access has increased, some patients have been found to have symptoms such as abnormal hand sensation and inflexibility after the procedure. The primary objective is to assess hand function after coronary diagnosis and intervention via distal vs conventional radial access at 24 hours and 1 month. Hand sensory and motor dysfunction will be assessed by: * Consultation and physical examination * Hand grip test * Hand pinch test (lateral pinch) * Monofilament sensory test * Quick DASH questionnaire * High-frequent ultrasound The other endpoints include the success rate of puncture, the success rate of single-attempt puncture, time of puncture, procedural duration, duration of hemostasis, vascular complication, etc.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
640
Half of the patients enrolled in the study undergoing coronary diagnosis and intervention will be randomized conventional radial access for cardiac catheterization.
Half of the patients enrolled in the study undergoing coronary diagnosis and intervention will be randomized distal radial access for cardiac catheterization.
Hand Numbness
Number of participants with the hand numbness is evaluated through clinical consultations at 24 hours after procedure.
Time frame: 24 hours after procedure
Nerve Injury
Number of participants with the nerve injury is detected using high-frequent ultrasound or electromyography at 24 hours after procedure, and patients with nerve injury at 1 month follow-up will be recorded.
Time frame: 24 hours and 1 month after procedure
Thumb and Index Finger Pinch Test
Thumb and forefinger lateral pinch strength (kg)
Time frame: 24 hours before and after procedure, 1 month after procedure
Hand Grip Test
Hand grip strength test (kg)
Time frame: 24 hours before and after procedure, 1 month after procedure
Late-term Hand Numbness
Number of participants with the hand numbness is evaluated through clinical consultations at 1 month after procedure.
Time frame: 1 month after procedure
Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire (0-100)
Upper extremity dysfunction questionnaire. Scores range from 0 to 100, with higher scores indicating greater dysfunction.
Time frame: 24 hours before procedure and 1 month after procedure
Visual Analogue Scale (VAS) Scale (0-10)
Pain assessment. Scores range from 0 to 10, with higher scores indicating greater pain intensity.
Time frame: 24 hours after procedure
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Hand Paresthesia
Number of participants with the hand paresthesia is assessed using monofilament test and/or two-point discrimination test at 24 hours after procedure, and patients with hand paresthesia at 1 month follow-up will be recorded.
Time frame: 24 hours and 1 month after procedure
Hand Clumsiness
Number of participants with the hand clumsiness at 24 hours after procedure, and patients with hand clumsiness at 1 month follow-up will be recorded.
Time frame: 24 hours and 1 month after procedure