Tokyo, Oct. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059529) titled 'Efficacy of Ultrasound-Guided Distal Radial Artery Catheterization versus Radial Artery Catheterization in Prone Position Surgery and the Effects on Intraoperative Arterial Pressure Waveforms: a randomised controlled trial' on Oct. 24.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Keio University
Condition:
Condition - Prone Position Surgery
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study compares the radial artery and distal radial artery for ultrasound-guided arterial pressure line insertion using a T-shaped probe in patients undergoing prone position surgery, evaluating the rate of arterial pressure waveform damping during surgery.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Insertion of arterial line from distal radial artery
Interventions/Control_2 - Insertion of arterial line from radial artery
Eligibility:
Age-lower limit - 15
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients aged 15 years or older undergoing scheduled surgery in the prone position who require invasive arterial pressure monitoring
Key exclusion criteria - Patients with signs of infection at the puncture site.
Patients with coagulopathy.
Patients with a history of peripheral arterial disease.
Patients undergoing surgery in which intraoperative observation of the insertion site is anticipated to be difficult.
Target Size - 120
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 31 Day
Anticipated trial start date - 2025 Year 11 Month 01 Day
Last follow-up date - 2028 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068093
Disclaimer: Curated by HT Syndication.
