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Non-invasive Hemoglobin Monitoring in Outpatient Total Joint Arthroplasty

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05369325
Collaborator
(none)
200
Enrollment
1
Location
24
Anticipated Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This research is being done to better understand the accuracy of noninvasive hemoglobin tests on patients that recently underwent total joint arthroplasty.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Accuracy of Non-invasive Hemoglobin Monitoring in Patients Undergoing Outpatient Total Joint Arthroplasty
    Actual Study Start Date :
    Jun 15, 2022
    Anticipated Primary Completion Date :
    Jun 15, 2024
    Anticipated Study Completion Date :
    Jun 16, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Concordance between non-invasive Hgb and serum Hgb [1 hour]

      How closely the non-invasive and serum Hgbs correlate with one another statistically

    2. Patient satisfaction with non-invasive Hgb [1 day]

      Patients will get a survey to fill out following the Hgb measurements that assesses their satisfaction with the non-invasive method

    3. Nurse satisfaction with non-invasive Hgb [1 day]

      Nurses will get a survey to fill out following the Hgb measurements that assesses their satisfaction with the non-invasive method

    4. Cost comparison between non-invasive and serum Hgb [1 year]

      We will analyze cost differences between the non-invasive Hgb devices and the serum lab tests

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Adult patients age ≥ 18.

    • Undergoing either primary total knee or total hip arthroplasty for a primary underlying diagnosis of osteoarthritis.

    Exclusion Criteria:
    • Individuals < 18 years of age.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Matthew Abdel, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Matthew P. Abdel, M.D., Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05369325
    Other Study ID Numbers:
    • 22-000012
    First Posted:
    May 11, 2022
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 27, 2022