Hospital Medical Emergency TeamNCT02986581
Prospective Cohort Study of Rapid Response Team
An observational study of Hospital Medical Emergency Team and Medicine, Emergency, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to collect data of rapid response team activated patients prospectively Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Hospital Medical Emergency Team, Medicine, Emergency, Hospital Rapid Response Team
- How many people
- 79,800 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2016to Nov 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted to general ward in Seoul National University Bundang Hospital and monitored by in-hospital rapid response system.
Who may be able to join
- Patients admitted to general ward in Seoul National University Bundang Hospital and monitored by in-hospital rapid response system.
Who cannot join
- patients admitted to pediatric wards
- patients in emergency room, intensive care unit, and operating room
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yeon Joo Lee, MD contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si
Yeon Joo Lee, MD, +82317877082, yjlee1117@snubh.org
About this study
The purpose of this study is to collect data of rapid response team activated patients prospectively
Read the detailed description
acutely deteriorating patients including sudden cardiac arrest in general ward who are monitored and intervened by rapid response team
- Medical subject headings
- Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality or ICU admission of rapid response team activated patient
Measured: an average of 1 year
incidence of preventable cardiac arrest
Measured: an average of 1 year
Secondary outcomes (8)
Frequency of triggerring criteria(1) for activation of rapid response team
SBP <90mmHg(mABP 60mmHg) +- clinically correlated symptom or sign
Measured: an average of 1 year
Frequency of triggerring criteria(2) for activation of rapid response team
HR: <50/min or >140/min or symptomatic arrythmia
Measured: an average of 1 year
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
Measured: an average of 1 year
Frequency of triggerring criteria(4) for activation of rapid response team
Oxygenation: SaO2 <90% in room air or FM 8L/min
Measured: an average of 1 year
Frequency of triggerring criteria(5) for activation of rapid response team
Metabolic acidosis: Lactic acid<2.5 , TCO2 <15
Measured: an average of 1 year
Frequency of triggerring criteria(6) for activation of rapid response team
ABGA abnormality : PaCO2>50 or pH<7.3 or PaO2<60
Measured: an average of 1 year
Frequency of triggerring criteria(7) for activation of rapid response team
ABGA abnormality : PaCO2>50 or pH<7.3 or PaO2<60
Measured: an average of 1 year
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
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2022 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital Medical Emergency TeamStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 79,800 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Responsible party
- Sponsor
- Investigators
- Yeon Joo Lee, MD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986581
- Sponsor's protocol ID
- SAFER_20161101
- Status last verified
- Jun 2021
- First submitted
- 4 Nov 2016
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Rapid Response Team
- ClinicalTrials.gov ID
- NCT02986581
- Acronym / sponsor ID
- SAFER_20161101
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 79,800 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Study start
- Nov 2016
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 8 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect data of rapid response team activated patients prospectively
Detailed description
acutely deteriorating patients including sudden cardiac arrest in general ward who are monitored and intervened by rapid response team
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to general ward in Seoul National University Bundang Hospital and monitored by in-hospital rapid response system.
Key inclusion criteria (1 listed)
- Patients admitted to general ward in Seoul National University Bundang Hospital and monitored by in-hospital rapid response system.
Key exclusion criteria (2 listed)
- patients admitted to pediatric wards
- patients in emergency room, intensive care unit, and operating room
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mortality or ICU admission of rapid response team activated patient
Time frame: an average of 1 year
incidence of preventable cardiac arrest
Time frame: an average of 1 year
8 secondary outcomes
Frequency of triggerring criteria(1) for activation of rapid response team
Time frame: an average of 1 year
Frequency of triggerring criteria(2) for activation of rapid response team
Time frame: an average of 1 year
Frequency of triggerring criteria(3) for activation of rapid response team
Time frame: an average of 1 year
Frequency of triggerring criteria(4) for activation of rapid response team
Time frame: an average of 1 year
Frequency of triggerring criteria(5) for activation of rapid response team
Time frame: an average of 1 year
Frequency of triggerring criteria(6) for activation of rapid response team
Time frame: an average of 1 year
Frequency of triggerring criteria(7) for activation of rapid response team
Time frame: an average of 1 year
Frequency of triggerring criteria(8) for activation of rapid response team
Time frame: an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yeon Joo Lee, MD contact
Yeon Joo Lee, MD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospital Medical Emergency Team and Medicine, Emergency, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yeon Joo Lee, MD (yjlee1117@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality or ICU admission of rapid response team activated patient (time frame: an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.