Evaluation of Pain and Discomfort in the Cardiac Catheterization Lab
1 other identifier
observational
175
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2020
CompletedFirst Posted
Study publicly available on registry
July 29, 2020
CompletedStudy Start
First participant enrolled
December 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedFebruary 3, 2023
January 1, 2022
5 months
July 24, 2020
February 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (2)
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
Study Arms (2)
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
Eligibility Criteria
Adult patients coming to Duke University for Cardiac Catheterization
You may qualify if:
- English speaking
- Coming to Duke University for Cardiac Catheterization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University
Durham, North Carolina, 27710, United States
Related Publications (1)
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.
PMID: 36640418RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Bradi Granger, PhD
Duke University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2020
First Posted
July 29, 2020
Study Start
December 7, 2020
Primary Completion
April 30, 2021
Study Completion
April 30, 2021
Last Updated
February 3, 2023
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share