Nurse-led Sheath Insertion in Cardiac Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: nurse-led sheath insertion.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Procedure nurse-led sheath insertion
radial sheaths for coronary examination and intervention are performed by experienced nurses
Primary outcome measures
- pain level [Time frame: through study completion, an average of 1 year]
- comfort level [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (4)
- success rate [Time frame: through study completion, an average of 1 year]
- time consumption [Time frame: through study completion, an average of 1 year]
- convertion [Time frame: through study completion, an average of 1 year]
- complications [Time frame: through study completion, an average of 1 year]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Zealand University Hospital — Roskilde
Identifiers
NCT: NCT05470335 · EMN-2021-08143