Clincosm LogoSign in Get a demo

Comparison of Different Locations for Pulse Oximetry Probes in Cardiovascular (CV) Patients With Poor Peripheral Perfusion

Sponsor
Saint Luke's Health System (Other)
Overall Status
Terminated
CT.gov ID
NCT01128036
Collaborator
Medtronic - MITG (Industry)
51
Enrollment
1
Location
12
Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if the forehand location for sensor placement has less episodes of signal dropout than the finger sensor location. In addition, this study will evaluate two finger sensors, which utilize different technology to compare signal quality.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A comparison study design will be used to evaluate the signal quality of pulse oximetry sensors placed in two locations: forehand and finger. Each subject will serve as their own control, with measurements of signal quality evaluated at 2 second intervals over a period of one hour. The measurements will be recorded simultaneously with a computer program and laptop computer. Finger and forehand sensors will be applied according to manufacturer's guidelines. An output connection will be made from each pulse oximeter computer unit to a password protected, laptop computer for data downloading. Data will be collected for a 1 hour period at 2 second increments and stored in the hard drive of the laptop. Following completion of data collection, the study sensors will be removed.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    51 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Comparison of Different Locations for Pulse Oximetry Probes in Adult Cardiovascular Patients With Poor Peripheral Perfusion
    Study Start Date :
    May 1, 2010
    Actual Primary Completion Date :
    May 1, 2011
    Actual Study Completion Date :
    May 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    CHF, cardomyopathy

    Patients with signs of poor peripheral perfusion due to cardiomyopathy or congestive heart failure

    Outcome Measures

    Primary Outcome Measures

    1. Signal quality loss (dropout rate) [Every 2 seconds for one hour]

    Eligibility Criteria

    Criteria

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

    • CICU patients with a new diagnosis or history of CHF or cardiomyopathy

    • Patients with a medical order for pulse oximetry monitoring

    • Age greater than or equal to 18 years of age

    • English speaking

    • Signs of hypoperfusion

    Exclusion Criteria:

    • CICU patients with an impediment to sensor application

    • CICU patients with excessive facial edema

    • CICU patients with mechanical ventilation

    • CICU patients with intra-aortic balloon pump therapy

    • CICU patients with intravenous vasopressor drug administration

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Saint Luke's Hospital Kansas City Missouri United States 64111

    Sponsors and Collaborators

    • Saint Luke's Health System
    • Medtronic - MITG

    Investigators

    • Study Director: Lisa Riggs, MSN, Saint Luke's Hospital
    • Principal Investigator: Marci Sportsman, BSN, Saint Luke's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01128036
    Other Study ID Numbers:
    • COVMOPO0054
    First Posted:
    May 21, 2010
    Last Update Posted:
    Aug 9, 2011
    Last Verified:
    Aug 1, 2011
    Keywords provided by , ,
    Congestive Heart failure
    Cardiomyopathy
    Additional relevant MeSH terms:
    Heart Failure
    Cardiomyopathies

    Study Results

    No Results Posted as of Aug 9, 2011