Coronary Artery DiseaseNUSHINCT05470335
Nurse-led Sheath Insertion in Cardiac Patients
A study testing nurse-led sheath insertion in people with Coronary Artery Disease, run by Zealand University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- nurse-led sheath insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2022to Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients suspected of having coronary artery disease
- with normal puls oxymetry on the right hand
- understands patient information and accepts to participate
Who cannot join
- under consideration for cardiac valve replacement
- systolic blood pressure persistently >180 mmHg
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Zealand University Hospital
Roskilde, Danmark, DK 4000
Henning Kelbaek, 20230078, heke@regionsjaelland.dkdadlnet.dk
Connie Olsen, 47326169, clo@reionsjaelland.dk
About this study
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
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- nurse-led sheath insertion
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nurse-led sheath insertionProcedure or surgery
radial sheaths for coronary examination and intervention are performed by experienced nurses
| Study group | Role | What they receive |
|---|---|---|
| physician insertion | No intervention | radial sheath insertion is performed by physicians |
| nurse insertion | Experimental | radial sheath insertion is performed by nurses Receives: Procedure: nurse-led sheath insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
success rate
success rate with regard to successful sheath insertion is assured
Measured: through study completion, an average of 1 year
time consumption
time consumption for both groups
Measured: 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
Measured: through study completion, an average of 1 year
complications
occurrence of radial occlusion, perforation, pseudoaneurysm, and compartment syndrome
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start1 Sep 2022
- Primary completionSep 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henning Kelbæk, MD, Principal investigator, Chief Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470335
- Sponsor's protocol ID
- EMN-2021-08143
- Acronym
- NUSHI
- Status last verified
- Aug 2024
- First submitted
- 31 May 2022
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05470335
- Acronym / sponsor ID
- NUSHI / EMN-2021-08143
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physician insertion | No intervention | –radial sheath insertion is performed by physicians |
| nurse insertion | Experimental | Procedure: nurse-led sheath insertionradial sheath insertion is performed by nurses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients suspected of having coronary artery disease
- with normal puls oxymetry on the right hand
- understands patient information and accepts to participate
Key exclusion criteria (2 listed)
- under consideration for cardiac valve replacement
- systolic blood pressure persistently >180 mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nurse-led sheath insertionradial sheaths for coronary examination and intervention are performed by experienced nurses | Procedure or surgery | nurse insertion |
Primary outcome
pain level
Time frame: 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.
comfort level
Time frame: 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.
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henning Kelbæk, MD principal investigator
Chief Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nurse-led sheath insertion in people with Coronary Artery Disease, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henning Kelbaek, MD (20230078, heke@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain level (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.