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Nurse-led Sheath Insertion in Cardiac Patients (NUSHI)

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
nurse-led sheath insertion
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zealand University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

physician insertion

nurse insertion

Arm Description

radial sheath insertion is performed by physicians

radial sheath insertion is performed by nurses

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

success rate
success rate with regard to successful sheath insertion is assured
time consumption
time consumption for both groups
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
complications
occurrence of radial occlusion, perforation, pseudoaneurysm, and compartment syndrome

Full Information

First Posted
May 31, 2022
Last Updated
January 25, 2023
Sponsor
Zealand University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05470335
Brief Title
Nurse-led Sheath Insertion in Cardiac Patients
Acronym
NUSHI
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
physician insertion
Arm Type
No Intervention
Arm Description
radial sheath insertion is performed by physicians
Arm Title
nurse insertion
Arm Type
Experimental
Arm Description
radial sheath insertion is performed by nurses
Intervention Type
Procedure
Intervention Name(s)
nurse-led sheath insertion
Intervention Description
radial sheaths for coronary examination and intervention are performed by experienced nurses
Primary Outcome Measure Information:
Title
pain level
Description
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 year
Title
comfort level
Description
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 year
Secondary Outcome Measure Information:
Title
success rate
Description
success rate with regard to successful sheath insertion is assured
Time Frame
through study completion, an average of 1 year
Title
time consumption
Description
time consumption for both groups
Time Frame
through study completion, an average of 1 year
Title
convertion
Description
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 year
Title
complications
Description
occurrence of radial occlusion, perforation, pseudoaneurysm, and compartment syndrome
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henning Kelbaek, MD
Phone
20230078
Email
heke@regionsjaelland.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Connie Olsen, RN
Phone
47326169
Email
clo@regionsjaelland.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henning Kelbæk, MD
Organizational Affiliation
Chief Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zealand University Hospital
City
Roskilde
State/Province
Danmark
ZIP/Postal Code
DK 4000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henning Kelbaek
Phone
20230078
Email
heke@regionsjaelland.dkdadlnet.dk
First Name & Middle Initial & Last Name & Degree
Connie Olsen
Phone
47326169
Email
clo@reionsjaelland.dk
First Name & Middle Initial & Last Name & Degree
Yama Fakhri, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Nurse-led Sheath Insertion in Cardiac Patients

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