Nurse-led Sheath Insertion in Cardiac Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: nurse-led sheath insertion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |