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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1052210056
Enrollment
264
Registered
2021-07-29
Start date
2021-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial line insufficiency

Interventions

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 tim

Sponsors

Minami Kimito
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactKimito Minami

National Cerebral and Cardiovasculae Center

k.minami@ncvc.go.jp+81-661701070

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026