Clincosm LogoSign in Get a demo

Prospective Cohort Study of Rapid Response Team

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT02986581
Collaborator
Seoul National University Bundang Hospital (Other)
79,800
Enrollment
1
Location
120
Duration (Months)
665.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to collect data of rapid response team activated patients prospectively

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    acutely deteriorating patients including sudden cardiac arrest in general ward who are monitored and intervened by rapid response team

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    79800 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Study Start Date :
    Nov 1, 2016
    Anticipated Primary Completion Date :
    Nov 1, 2022
    Anticipated Study Completion Date :
    Nov 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. mortality or ICU admission of rapid response team activated patient [an average of 1 year]

    2. incidence of preventable cardiac arrest [an average of 1 year]

    Secondary Outcome Measures

    1. Frequency of triggerring criteria(1) for activation of rapid response team [an average of 1 year]

      SBP <90mmHg(mABP 60mmHg) +- clinically correlated symptom or sign

    2. Frequency of triggerring criteria(2) for activation of rapid response team [an average of 1 year]

      HR: <50/min or >140/min or symptomatic arrythmia

    3. Frequency of triggerring criteria(3) for activation of rapid response team [an average of 1 year]

      RR: <10/min or >30/min or stridor(sign of airway obstruction) or accessary muscle use

    4. Frequency of triggerring criteria(4) for activation of rapid response team [an average of 1 year]

      Oxygenation: SaO2 <90% in room air or FM 8L/min

    5. Frequency of triggerring criteria(5) for activation of rapid response team [an average of 1 year]

      Metabolic acidosis: Lactic acid<2.5 , TCO2 <15

    6. Frequency of triggerring criteria(6) for activation of rapid response team [an average of 1 year]

      ABGA abnormality : PaCO2>50 or pH<7.3 or PaO2<60

    7. Frequency of triggerring criteria(7) for activation of rapid response team [an average of 1 year]

      ABGA abnormality : PaCO2>50 or pH<7.3 or PaO2<60

    8. Frequency of triggerring criteria(8) for activation of rapid response team [an average of 1 year]

      Any serious concern about overall deterioration detected by doctor, nurse and caregiver at bedside

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients admitted to general ward in Seoul National University Bundang Hospital and monitored by in-hospital rapid response system.
    Exclusion Criteria:

    • patients admitted to pediatric wards

    • patients in emergency room, intensive care unit, and operating room

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of

    Sponsors and Collaborators

    • Seoul National University Hospital
    • Seoul National University Bundang Hospital

    Investigators

    • Principal Investigator: Yeon Joo Lee, MD, Seoul National University Bundang Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT02986581
    Other Study ID Numbers:
    • SAFER_20161101
    First Posted:
    Dec 8, 2016
    Last Update Posted:
    Jun 30, 2021
    Last Verified:
    Jun 1, 2021
    Additional relevant MeSH terms:
    Emergencies

    Study Results

    No Results Posted as of Jun 30, 2021