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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02986581
Other study ID # SAFER_20161101
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2016
Est. completion date November 2026

Study information

Verified date June 2021
Source Seoul National University Hospital
Contact Yeon Joo Lee, MD
Email yjlee1117@snubh.org
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 79800
Est. completion date November 2026
Est. primary completion date November 2022
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility 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 Design


Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si

Sponsors (2)

Lead Sponsor Collaborator
Seoul National University Hospital Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary mortality or ICU admission of rapid response team activated patient an average of 1 year
Primary incidence of preventable cardiac arrest an average of 1 year
Secondary Frequency of triggerring criteria(1) for activation of rapid response team SBP <90mmHg(mABP 60mmHg) +- clinically correlated symptom or sign an average of 1 year
Secondary Frequency of triggerring criteria(2) for activation of rapid response team HR: <50/min or >140/min or symptomatic arrythmia an average of 1 year
Secondary Frequency of triggerring criteria(3) for activation of rapid response team RR: <10/min or >30/min or stridor(sign of airway obstruction) or accessary muscle use an average of 1 year
Secondary Frequency of triggerring criteria(4) for activation of rapid response team Oxygenation: SaO2 <90% in room air or FM 8L/min an average of 1 year
Secondary Frequency of triggerring criteria(5) for activation of rapid response team Metabolic acidosis: Lactic acid<2.5 , TCO2 <15 an average of 1 year
Secondary Frequency of triggerring criteria(6) for activation of rapid response team ABGA abnormality : PaCO2>50 or pH<7.3 or PaO2<60 an average of 1 year
Secondary Frequency of triggerring criteria(7) for activation of rapid response team ABGA abnormality : PaCO2>50 or pH<7.3 or PaO2<60 an average of 1 year
Secondary Frequency of triggerring criteria(8) for activation of rapid response team Any serious concern about overall deterioration detected by doctor, nurse and caregiver at bedside an average of 1 year
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04507737 - Rapid Response Teams - How and Who? N/A
Completed NCT01551160 - Impact of a Communication and Team-working Intervention on Performance and Effectiveness of a Medical Emergency Team N/A
Not yet recruiting NCT04951973 - Deep Learning Based Early Warning Score in Rapid Response Team Activation