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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| physician insertion | No Intervention | radial sheath insertion is performed by physicians | |
| nurse insertion | Experimental | radial sheath insertion is performed by nurses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nurse-led sheath insertion | Procedure | radial sheaths for coronary examination and intervention are performed by experienced nurses |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Henning Kelbaek, MD | Contact | 20230078 | heke@regionsjaelland.dk | |
| Connie Olsen, RN | Contact | 47326169 | clo@regionsjaelland.dk |
| Name | Affiliation | Role |
|---|---|---|
| Henning Kelbæk, MD | Chief Physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zealand University Hospital | Recruiting | Roskilde | Danmark | DK 4000 | Denmark |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |