Nurse-led Sheath Insertion in Cardiac Patients
ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZealand University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients suspected of having coronary artery disease
with normal puls oxymetry on the right hand
understands patient information and accepts to participate
Disqualifiers
under consideration for cardiac valve replacement
systolic blood pressure persistently >180 mmHg
Trial design
Design model
Parallel
Treatments tested in this trial
nurse-led sheath insertion
Procedure/Surgeryradial sheaths for coronary examination and intervention are performed by experienced nurses
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: physician insertionNo intervention 0 interventions
Group B: nurse insertionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
through study completion, an average of 1 year2
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 yearSecondary outcomes
1
success rate
success rate with regard to successful sheath insertion is assured
Time frame
through study completion, an average of 1 year2
time consumption
time consumption for both groups
Time frame
through study completion, an average of 1 year3
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 year4
complications
occurrence of radial occlusion, perforation, pseudoaneurysm, and compartment syndrome
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov