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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,000
radial sheaths for coronary examination and intervention are performed by experienced nurses
Zealand University Hospital
Roskilde, Danmark, Denmark
RECRUITINGpain 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.
Time frame: 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.
Time frame: through study completion, an average of 1 year
success rate
success rate with regard to successful sheath insertion is assured
Time frame: through study completion, an average of 1 year
time consumption
time consumption for both groups
Time frame: 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
Time frame: through study completion, an average of 1 year
complications
occurrence of radial occlusion, perforation, pseudoaneurysm, and compartment syndrome
Time frame: through study completion, an average of 1 year
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