Nurse-led Sheath Insertion in Cardiac Patients (NUSHI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: nurse-led sheath insertion

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 Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Henning Kelbaek, MD; Phone Number: 20230078; Email: heke@regionsjaelland.dk
• Study Contact Backup: Name: Connie Olsen, RN; Phone Number: 47326169; Email: clo@regionsjaelland.dk

Study Locations

• Denmark
  • Danmark
    • Roskilde, Danmark, Denmark, DK 4000
      • Recruiting
      • Zealand University Hospital
      • Contact: Henning Kelbaek; Phone Number: 20230078; Email: heke@regionsjaelland.dkdadlnet.dk
      • Contact: Connie Olsen; Phone Number: 47326169; Email: clo@reionsjaelland.dk
      • Sub-Investigator: Yama Fakhri, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: physician insertion; radial sheath insertion is performed by physicians
Experimental: nurse insertion; radial sheath insertion is performed by nurses	Procedure: nurse-led sheath insertion; radial sheaths for coronary examination and intervention are performed by experienced nurses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
success rate	success rate with regard to successful sheath insertion is assured	through study completion, an average of 1 year
time consumption	time consumption for both groups	through study completion, an average of 1 year
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
complications	occurrence of radial occlusion, perforation, pseudoaneurysm, and compartment syndrome	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Investigators: Principal Investigator: Henning Kelbæk, MD, Chief Physician

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): September 1, 2025
• Study Completion (Anticipated): September 1, 2026

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: EMN-2021-08143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No