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The purpose of this study is to explore how the timing of procedural sedation medications influences patient comfort and satisfaction with sedation.
Participation in this study will included be randomly assigned to one of two groups (long and short) within standard of care. Each group will observe a time interval between receiving procedural sedation medications and the start of the procedure. A trained observer will evaluate patient experience during the procedure and at the end of the procedure we will ask the participant 3 brief questions about the experience. All other information collected about the experience during the procedure will occur as part of usual care. No further activities will be asked as part of this study. All study activities will occur during a scheduled visit and participation is complete once questions have been answered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1- short interval | Less than or equal to six minutes between receiving sedation and the start of the procedure | ||
| Group 2- long interval | Greater than or equal to seven minutes between receiving sedation and the start of the procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Total medication administration dosage as measured by the procedural database | During procedure, up to 2.5 hours | |
| Frequency of medication administration as measured by the procedural database | During procedure, up to 2.5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction as measured by Procedural Sedation Assessment Survey (PROSAS) | Within 2 hours of procedure | |
| Pain as measured by observation using the Behavioral Pain Assessment Tool (BPAT) | During procedure, to 2.5 hours |
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Inclusion Criteria:
Exclusion Criteria:
-
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Adult patients coming to Duke University for Cardiac Catheterization
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| Name | Affiliation | Role |
|---|---|---|
| Bradi Granger, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36640418 | Result | Mall A, Girton TA, Yardley K, Ronn M, Cross E, Smith PJ, Rossman P, McEwen T, Ohman EM, Jones WS, Granger BB. Timing of sedation and patient-reported pain outcomes during cardiac catheterization: Results from the UNTAP-intervention study. Catheter Cardiovasc Interv. 2023 Jan 14. doi: 10.1002/ccd.30535. Online ahead of print. |
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