Nurse-led Sheath Insertion in Cardiac Patients (NUSHI)

Zealand University Hospital

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Procedure: nurse-led sheath insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT05470335

EMN-2021-08143

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients suspected of having coronary artery disease
• with normal puls oxymetry on the right hand
• understands patient information and accepts to participate

Exclusion criteria

• under consideration for cardiac valve replacement
• systolic blood pressure persistently >180 mmHg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

physician insertion

No Intervention group

Description:

radial sheath insertion is performed by physicians

nurse insertion

Experimental group

Description:

radial sheath insertion is performed by nurses

Treatment:

Procedure: nurse-led sheath insertion