Randomized control trial of comparison in the incidence of arterial catheter insufficiency between polyethylene and polyurethane catheter.

JRCT ID: jRCT1052210056

Registered date:29/07/2021

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Atrial line insufficiency
• Date of first enrollment: 01/08/2021
• Target sample size: 264
• Study type: Interventional
• Intervention(s): After obtaining the consent of the target patients, random allocation will be performed to the test device group or control device group, and an open arterial pressure line will be inserted at the time of induction of general anesthesia. Attach an opaque dressing to the inserted device so that it cannot be identified from the outside. After surgery, move to the ICU under general anesthesia and compare the incidence of arterial pressure catheter dysfunction at the first noon after admission to the ICU.

Outcome(s)

Primary Outcome

Meet any of the signs of arterial catheter dysfunction defined below at the first noon after admission to the ICU.
1: Flattened pressure waveform improved by wearing a splint or adjusting the position of the hand
2: There is a flattened pressure waveform that does not improve by wearing a splint or adjusting the position of the hand, and there is a difference of 20 mmHg or more in systolic blood pressure compared to systolic non-invasive blood pressure measured in the upper arm on the same side. To be done
3: When the pressure transducer is opened to the atmosphere, it takes 2 seconds or more for blood reflux.
4: Blood cannot be collected from the arterial pressure catheter
5: The pressure flush of the arterial pressure catheter cannot be performed.

• Secondary Outcome: Occurrence of arterial pressure catheter dysfunction as the primary endpoint at the time of entering the ICU, 24 hours after entering the room, and 48 hours after entering the room.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Age > 18 y.o.
2) Patients undergoing standby cardiovascular surgery and scheduled for admission to the intensive care unit
3) patients with informed consent

• Exclude criteria: Body mass index > 35 kg/m2, infection at the site of atrial catheterization, Raynaud's disease, Burger disease, patients with left ventricular assist device, veno-arterial extracorporeal membrane oxygenation, intrasortic baloon pumping, or hemodialysis, patients with significant valuvlar disease, Allen's test >= 5 seconds.

Related Information

• Primary Sponsor: Minami Kimito
• Source(s) of Monetary Support: VYGON FRANCE