Nurse-led Sheath Insertion in Cardiac Patients

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease
• Interventions: Procedure: nurse-led sheath insertion

• Registration Number: NCT05470335
• Lead Sponsor: Zealand University Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2022-05-31
• Study First Submitted QC: 2022-07-21
• Study First Posted: 2022-07-22
• Study Start: 2022-09-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nurse insertion	nurse-led sheath insertion	radial sheath insertion is performed by nurses

Primary Outcome Measures

Name	Time	Method
pain level	through study completion, an average of 1 year	pain level during sheath insertion is measured using a 1 to 10 point numeric rating scale. For pain registration: 0 is no pain and 10 the worst imaginable pain.
comfort level	through study completion, an average of 1 year	comfort level during sheath insertion is measured using a 1 to 10 point numeric rating scale. For comfort: 0 is no comfort at all and 10 is the best imaginable comfort.

Secondary Outcome Measures

Name	Time	Method
convertion	through study completion, an average of 1 year	successful conversion yes/no from physician to nurse or from nurse to physician determined by the possibility to accomplish the diagnostic or therapeutic procedure
time consumption	through study completion, an average of 1 year	time consumption for both groups
complications	through study completion, an average of 1 year	occurrence of radial occlusion, perforation, pseudoaneurysm, and compartment syndrome
success rate	through study completion, an average of 1 year	success rate with regard to successful sheath insertion is assured

Trial Locations

Locations (1)

Zealand University Hospital; 🇩🇰 Roskilde, Danmark, Denmark