Nurse-led sheath insertion for 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
This study tests if nurses can safely and comfortably insert sheaths for heart patients just as well as doctors do.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zealand University Hospital Academic / other |
| Locations | 1 site (Roskilde, Danmark) |
| Trial ID | NCT05470335 on ClinicalTrials.gov |
What this trial studies
This project aims to determine if nurses can perform radial sheath insertion for coronary artery disease patients with the same level of comfort and safety as physicians. Patients referred for coronary angiography or percutaneous coronary intervention will be randomized to receive sheath insertion by either a nurse or a physician. The study will measure comfort and pain levels immediately after the procedure and monitor for complications and adverse events over one year. The goal is to evaluate the feasibility of nurse-led procedures in a specialized medical setting.
Who should consider this trial
Good fit: Ideal candidates are patients suspected of having coronary artery disease who are scheduled for coronary angiography or PCI.
Not a fit: Patients who are under consideration for cardiac valve replacement or have persistently high blood pressure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the efficiency of cardiac procedures and expand the role of nurses in invasive cardiology.
How similar studies have performed: While the specific approach of nurse-led sheath insertion is novel, similar studies have shown that trained nurses can safely perform various invasive procedures.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Roskilde, Danmark
- Zealand University Hospital — Roskilde, Danmark, Denmark (Recruiting)
Study contacts
- Principal investigator: Henning Kelbæk, MD — Chief Physician
- Study coordinator: Henning Kelbaek, MD
- Email: heke@regionsjaelland.dk
- Phone: 20230078
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.