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The Critical Threshold of Pulse Oximetry Plethysmographic Waveform Parameters in High Quality CPR

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03754946
Collaborator
(none)
1,000
Enrollment
1
Location
40
Anticipated Duration (Months)
25
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to analyze the relationship of the area under the curve (AUC) and/or the amplitude (Amp) of pulse oximetry plethysmographic waveform (POP) with partial pressure of end-tidal carbon dioxide (PETCO2) which could be used to reflect its quality in cardiopulmonary resuscitation (CPR), and then to determine the critical threshold of POP parameters in high quality CPR.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Actual Study Start Date :
    Sep 1, 2015
    Actual Primary Completion Date :
    Jun 30, 2018
    Anticipated Study Completion Date :
    Dec 31, 2018

    Outcome Measures

    Primary Outcome Measures

    1. the cut-off value of POP parameters in High Quality CPR [one year]

      Describe the the cut-off value of POP parameters in High Quality CPR. Receiver operating curve analysis was performed to evaluate the accuracy in predicting return of spontaneous circulation (ROSC).

    2. Compare different predictors [one year]

      Area under curve (AUC) between potential predictors was compared by using a nonparametric test, and the optimal cutoff point was determined by estimating the Youden's index.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Cardiac arrested

    • The time from cardiac arrest to receiving basic life support is less than 10 minutes

    • Get advanced life support (endotracheal intubation and PETCO2 monitoring)

    Exclusion Criteria:

    • Defuse CPR

    • chronic obstructive pulmonary disease (COPD) with type II respiratory failure

    • Terminal malignant tumors or terminal stage of other diseases

    • Rib fracture

    • Cardiac arrest caused by hemorrhagic shock pulmonary embolism and cardiac tamponade

    • Sever anemia(HGB<7g/dl)

    • Untreated tension pneumothorax

    • Tinea unguium, dyeing Fingernails and other factors affect the monitor of Pulse Oximetry Plethysmographic Waveform such vasculitis and Raynaud's phenomenon

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking Union Medical College Hospital Beijing China 100730

    Sponsors and Collaborators

    • Peking Union Medical College Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT03754946
    Other Study ID Numbers:
    • 201502019
    First Posted:
    Nov 27, 2018
    Last Update Posted:
    Nov 27, 2018
    Last Verified:
    Nov 1, 2018
    Keywords provided by Peking Union Medical College Hospital
    cardiopulmonary resuscitation
    pulse oximetry plethysmographic waveform
    quality monitor
    partial pressure of end-tidal carbon dioxide

    Study Results

    No Results Posted as of Nov 27, 2018