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Evaluation of Pain and Discomfort in the Cardiac Catheterization Lab

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT04490369
Collaborator
(none)
175
Enrollment
1
Location
4.7
Actual Duration (Months)
37
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    175 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Pain and Discomfort in the Cardiac Catheterization Lab
    Actual Study Start Date :
    Dec 7, 2020
    Actual Primary Completion Date :
    Apr 30, 2021
    Actual Study Completion Date :
    Apr 30, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Total medication administration dosage as measured by the procedural database [During procedure, up to 2.5 hours]

    2. Frequency of medication administration as measured by the procedural database [During procedure, up to 2.5 hours]

    Secondary Outcome Measures

    1. Patient satisfaction as measured by Procedural Sedation Assessment Survey (PROSAS) [Within 2 hours of procedure]

    2. Pain as measured by observation using the Behavioral Pain Assessment Tool (BPAT) [During procedure, to 2.5 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • English speaking

    • Coming to Duke University for Cardiac Catheterization

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Duke University Durham North Carolina United States 27710

    Sponsors and Collaborators

    • Duke University

    Investigators

    • Principal Investigator: Bradi Granger, PhD, Duke University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT04490369
    Other Study ID Numbers:
    • Pro00102686
    First Posted:
    Jul 29, 2020
    Last Update Posted:
    Feb 9, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Duke University
    Procedural sedation
    Cardiac Catheterization

    Study Results

    No Results Posted as of Feb 9, 2022