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NCT Number: NCT05470335

Nurse-led Sheath Insertion in 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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nurse-led sheath insertion

Procedure

radial sheaths for coronary examination and intervention are performed by experienced nurses

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. success rate

    Time frame: through study completion, an average of 1 year

    success rate with regard to successful sheath insertion is assured

  2. time consumption

    Time frame: through study completion, an average of 1 year

    time consumption for both groups

  3. convertion

    Time frame: through study completion, an average of 1 year

    successful conversion yes/no from physician to nurse or from nurse to physician determined by the possibility to accomplish the diagnostic or therapeutic procedure

  4. complications

    Time frame: through study completion, an average of 1 year

    occurrence of radial occlusion, perforation, pseudoaneurysm, and compartment syndrome

Study contacts

Contact information is provided by the study sponsor or research team.

Connie Olsen, RN

CONTACT

[email protected]

47326169

Henning Kelbaek, MD

CONTACT

[email protected]

20230078

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study 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

Acronym: NUSHI

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jul 22, 2022
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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