NCT05470335

Nurse-led Sheath Insertion in Cardiac Patients

Patient Comfort, Success Rate, Procedure Time and Complications During Sheath Insertion by Nurses and Physicians in Connection With Invasive Examination and Treatment of Cardiac Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Zealand University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of project NUSHI is to elucidate, that radial sheath insertion can be performed by nurses and physicians with the same level of comfort and safety.

Detailed description

Background: Insertion of sheath in the radial artery in connection with examination and treatment of patients with coronary artery disease is usually performed by specialized invasive cardiologists or trainees. Whether sheath insertion can be performed by nurses with the same level of comfort and pain is uncertain. Eligibility: Patients referred for coronary angiography (CAG) and/or percutaneous coronary intervention (PCI) due to suspicion of coronary artery disease are included Randomization: Patients are randomized 1:1 to sheath insertion by nurse or physician Methods: Insertion of 5 or 6 radial sheaths is performed in local anesthesia Outcome measures: Comfort and pain level is registered from immediately after sheath insertion until start of CAG/PCI. Additional outcome measures: Oximetry test is performed immediately after sheath removal - and repeated after 1 month in case of occlusion. Any complication is recorded from the patient enters the wake-up room until discharge. All patients are contacted after 1 year in order to register adverse events.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	nurse-led sheath insertion	radial sheaths for coronary examination and intervention are performed by experienced nurses

Timeline

• Start date: 2022-09-01
• Primary completion: 2025-09-01
• Completion: 2026-09-01
• First posted: 2022-07-22
• Last updated: 2024-08-06

Locations

1 site across 1 country: Denmark