Evaluation of Pain and Discomfort in the Cardiac Catheterization Lab

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.

Study Overview

• Status: Completed
• Conditions: Patient Comfort

• Study Type: Observational
• Enrollment (Actual): 175

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients coming to Duke University for Cardiac Catheterization

Description

Inclusion Criteria:

• English speaking
• Coming to Duke University for Cardiac Catheterization

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Bradi Granger, PhD, Duke University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2020
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: July 24, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): February 3, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Procedural sedation; Cardiac Catheterization
• Other Study ID Numbers: Pro00102686

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No