Nurse-led Sheath Insertion in Cardiac Patients

Coronary Artery Disease Clinical Trial

— NUSHI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05470335
• Other study ID #: EMN-2021-08143
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: September 2026

Study information

• Verified date: January 2023
• Source: Zealand University Hospital
• Contact: Henning Kelbaek, MD
• Phone: 20230078
• Email: heke[@]regionsjaelland.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• nurse-led sheath insertion
radial sheaths for coronary examination and intervention are performed by experienced nurses

Locations

Country	Name	City	State
Denmark	Zealand University Hospital	Roskilde	Danmark

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain level	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.	through study completion, an average of 1 year
Primary	comfort level	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.	through study completion, an average of 1 year
Secondary	success rate	success rate with regard to successful sheath insertion is assured	through study completion, an average of 1 year
Secondary	time consumption	time consumption for both groups	through study completion, an average of 1 year
Secondary	convertion	successful conversion yes/no from physician to nurse or from nurse to physician determined by the possibility to accomplish the diagnostic or therapeutic procedure	through study completion, an average of 1 year
Secondary	complications	occurrence of radial occlusion, perforation, pseudoaneurysm, and compartment syndrome	through study completion, an average of 1 year