- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02986581
Prospective Cohort Study of Rapid Response Team
June 27, 2021 updated by: Seoul National University Hospital
The purpose of this study is to collect data of rapid response team activated patients prospectively
Study Overview
Status
Recruiting
Detailed Description
acutely deteriorating patients including sudden cardiac arrest in general ward who are monitored and intervened by rapid response team
Study Type
Observational
Enrollment (Anticipated)
79800
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yeon Joo Lee, MD
- Email: yjlee1117@snubh.org
Study Locations
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-
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Seongnam-si, Korea, Republic of
- Recruiting
- Seoul National University Bundang Hospital
-
Contact:
- Yeon Joo Lee, MD
- Phone Number: +82317877082
- Email: yjlee1117@snubh.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients admitted to general ward in Seoul National University Bundang Hospital and monitored by in-hospital rapid response system.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mortality or ICU admission of rapid response team activated patient
Time Frame: an average of 1 year
|
an average of 1 year
|
incidence of preventable cardiac arrest
Time Frame: an average of 1 year
|
an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of triggerring criteria(1) for activation of rapid response team
Time Frame: an average of 1 year
|
SBP <90mmHg(mABP 60mmHg) +- clinically correlated symptom or sign
|
an average of 1 year
|
Frequency of triggerring criteria(2) for activation of rapid response team
Time Frame: an average of 1 year
|
HR: <50/min or >140/min or symptomatic arrythmia
|
an average of 1 year
|
Frequency of triggerring criteria(3) for activation of rapid response team
Time Frame: an average of 1 year
|
RR: <10/min or >30/min or stridor(sign of airway obstruction) or accessary muscle use
|
an average of 1 year
|
Frequency of triggerring criteria(4) for activation of rapid response team
Time Frame: an average of 1 year
|
Oxygenation: SaO2 <90% in room air or FM 8L/min
|
an average of 1 year
|
Frequency of triggerring criteria(5) for activation of rapid response team
Time Frame: an average of 1 year
|
Metabolic acidosis: Lactic acid<2.5 , TCO2 <15
|
an average of 1 year
|
Frequency of triggerring criteria(6) for activation of rapid response team
Time Frame: an average of 1 year
|
ABGA abnormality : PaCO2>50 or pH<7.3 or PaO2<60
|
an average of 1 year
|
Frequency of triggerring criteria(7) for activation of rapid response team
Time Frame: an average of 1 year
|
ABGA abnormality : PaCO2>50 or pH<7.3 or PaO2<60
|
an average of 1 year
|
Frequency of triggerring criteria(8) for activation of rapid response team
Time Frame: an average of 1 year
|
Any serious concern about overall deterioration detected by doctor, nurse and caregiver at bedside
|
an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Yeon Joo Lee, MD, Seoul National University Bundang Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Anticipated)
November 1, 2022
Study Completion (Anticipated)
November 1, 2026
Study Registration Dates
First Submitted
November 4, 2016
First Submitted That Met QC Criteria
December 6, 2016
First Posted (Estimate)
December 8, 2016
Study Record Updates
Last Update Posted (Actual)
June 30, 2021
Last Update Submitted That Met QC Criteria
June 27, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAFER_20161101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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