The aim of this study is to determine physician preference of sheath type based on a qualitative survey utilizing an EPIC-based randomization platform.
Physician's with patients undergoing diagnostic coronary angiography or percutaneous coronary intervention (PCI) via a planned radial artery access approach will be randomized to either the Terumo Glidesheath Slender or Merit Prelude Ideal radial artery sheath via an electronic medical record (EMR) (EPIC)-based randomization that will be conducted automatically prior to the procedure. The nursing team will set up the room as per usual and include the sheath that was identified in the randomization process. Physician's will complete the diagnostic coronary angiography and/or PCI per usual standard of care. Physicians will complete the questionnaire regarding their preferences at the end of the case. With the exception of the physician survey, the data to be reviewed will already exist as part of the standard EMR documentation. Datacore analysts will retrieve data of patients randomized from the EMR and populate in a database for analysis using a unique identifier that does not link the patients to their identifiable information (i.e. de-identified).
Study Type
OBSERVATIONAL
Enrollment
554
Terumo Glidesheath Slender sheath in the radial artery
Merit Prelude Ideal sheath in the radial artery
NYU Langone Health
New York, New York, United States
Physicians satisfaction score
Outcome measure is assessed by the Qualitative survey of physician satisfaction. The survey asks physicians to rate 6 items from 1 being the worst (very bad) to 5 being the best (very good) about the radial artery sheath used in their case. Total scores range from 6-30, with higher scores indicating greater satisfaction with the device.
Time frame: Within one day of procedure
Requirement of a skin nick to advance the sheath (yes/no)
Outcome measure is assessed by the Qualitative survey of physician satisfaction. Binary outcome of yes or no
Time frame: Within one day of procedure
Presence of leakage from the sheath's hemostatic valve during the procedure (yes/no)
Outcome measure is assessed by the Qualitative survey of physician satisfaction. Binary outcome of yes or no based on qualitative survey
Time frame: Within one day of procedure
Number of cases with radial artery spasm
Outcome measure is assessed by the Qualitative survey of physician satisfaction.
Time frame: Within one day of procedure
Number of cases with patient reported forearm pain
Outcome measure is assessed by the Qualitative survey of physician satisfaction.
Time frame: Within one day of procedure
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