Evaluation of Pain and Discomfort in the Cardiac Catheterization Lab

Patient Comfort Clinical Trial

Official title:

Evaluation of Pain and Discomfort in the Cardiac Catheterization Lab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04490369
• Other study ID #: Pro00102686
• Status: Completed
• Start date: December 7, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: January 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• English speaking
• Coming to Duke University for Cardiac Catheterization Exclusion Criteria: -

Related Conditions & MeSH terms

• Patient Comfort

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & 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 Cardiov — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total medication administration dosage as measured by the procedural database		During procedure, up to 2.5 hours
Primary	Frequency of medication administration as measured by the procedural database		During procedure, up to 2.5 hours
Secondary	Patient satisfaction as measured by Procedural Sedation Assessment Survey (PROSAS)		Within 2 hours of procedure
Secondary	Pain as measured by observation using the Behavioral Pain Assessment Tool (BPAT)		During procedure, to 2.5 hours