Transradial Access
Conditions
Keywords
transradial access, randomized trial, pragmatic EMR-based trial, TRA
Brief summary
The aim of this study is to determine physician preference of sheath type based on a qualitative survey utilizing an EPIC-based randomization platform.
Detailed description
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).
Interventions
DEVICETerumo Glidesheath Slender sheath
Terumo Glidesheath Slender sheath in the radial artery
DEVICEMerit Prelude Ideal sheath
Merit Prelude Ideal sheath in the radial artery
Sponsors
NYU Langone Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Physician has patient(s) undergoing diagnostic coronary angiography or percutaneous coronary intervention (PCI) across the NYU Langone Health enterprise will be eligible for the study.
Exclusion criteria
* No plan for at least one radial artery access * Physician preference to not participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physicians satisfaction score | Within one day of procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Requirement of a skin nick to advance the sheath (yes/no) | Within one day of procedure | Outcome measure is assessed by the Qualitative survey of physician satisfaction. Binary outcome of yes or no |
| Presence of leakage from the sheath's hemostatic valve during the procedure (yes/no) | Within one day of procedure | Outcome measure is assessed by the Qualitative survey of physician satisfaction. Binary outcome of yes or no based on qualitative survey |
| Number of cases with radial artery spasm | Within one day of procedure | Outcome measure is assessed by the Qualitative survey of physician satisfaction. |
| Number of cases with patient reported forearm pain | Within one day of procedure | Outcome measure is assessed by the Qualitative survey of physician satisfaction. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSunil Rao, MD
NYU Langone Health
Outcome results
None listed