Coronary Artery Disease
Conditions
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.
Interventions
PROCEDUREnurse-led sheath insertion
radial sheaths for coronary examination and intervention are performed by experienced nurses
Sponsors
Zealand University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| success rate | through study completion, an average of 1 year | success rate with regard to successful sheath insertion is assured |
| time consumption | through study completion, an average of 1 year | time consumption for both groups |
| 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 |
| complications | through study completion, an average of 1 year | occurrence of radial occlusion, perforation, pseudoaneurysm, and compartment syndrome |
Countries
Denmark
Contacts
Primary ContactHenning Kelbaek, MD
Backup ContactConnie Olsen, RN
Outcome results
None listed