A randomized controlled trial of proximal versus distal radial artery arterial pressure monitoring during and after transcatheter aortic valve implantation

JRCT ID: jRCT1032240557

Registered date:16/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients scheduled for transcatheter aortic valve implantation
• Date of first enrollment: 16/12/2024
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Proximal group: An arterial line under intraoperative management is inserted into the proximal radial artery.

Distal group: An arterial line under intraoperative management is inserted into the distal radial artery.

Outcome(s)

• Primary Outcome: Whether or not wrist exercise affects the arterial pressure waveform during arterial pressure monitoring

Secondary Outcome

1) Poor visualization of arterial pressure monitoring waveforms during surgery
2) Poor blood collection
3) Vascular lumen stenosis
4) Need for splint fixation
5) Degree of discomfort (Numerical Rating Scale: (NRS)) (after admission to the intensive care unit)
6) Time until removal of arterial line (after admission to the intensive care unit (ICU))
7) Time until discharge from the intensive care unit (after admission to the intensive care unit (ICU))

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who will undergo arterial pressure monitoring during surgery
2) Patients who are 65 years of age or older at the time of consent
3) Patients with no abnormalities in the radial artery
4) Patients who can obtain written consent from themselves or their legal representative

Exclude criteria

1) Patients with a lesion at the puncture site
2) Patients who have had a history of dialysis shunt surgery at the puncture site
3) Patients who are planning or may be undergoing dialysis shunt surgery at the puncture site in the future

Related Information

• Primary Sponsor: Yasuhisa Okuda