Nurse-led Sheath Insertion in Cardiac Patients
NUSHI
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
1 other identifier
interventional
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started Sep 2022
Typical duration for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2022
CompletedFirst Posted
Study publicly available on registry
July 22, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedAugust 6, 2024
August 1, 2024
3 years
May 31, 2022
August 5, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
success rate
through study completion, an average of 1 year
time consumption
through study completion, an average of 1 year
convertion
through study completion, an average of 1 year
complications
through study completion, an average of 1 year
Study Arms (2)
physician insertion
NO INTERVENTIONradial sheath insertion is performed by physicians
nurse insertion
EXPERIMENTALradial sheath insertion is performed by nurses
Interventions
radial sheaths for coronary examination and intervention are performed by experienced nurses
Eligibility Criteria
You may qualify if:
- patients suspected of having coronary artery disease
- with normal puls oxymetry on the right hand
- understands patient information and accepts to participate
You may not qualify if:
- under consideration for cardiac valve replacement
- systolic blood pressure persistently \>180 mmHg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zealand University Hospital
Roskilde, Danmark, DK 4000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henning Kelbæk, MD
Chief Physician
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2022
First Posted
July 22, 2022
Study Start
September 1, 2022
Primary Completion
September 1, 2025
Study Completion (Estimated)
September 1, 2026
Last Updated
August 6, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share