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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04951973
Other study ID # DEWS_2021
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 1, 2021
Est. completion date April 30, 2022

Study information

Verified date June 2021
Source Seoul National University Hospital
Contact Yeon Joo Lee, MD
Phone 82-31-787-7082
Email yjlee1117@snubh.org
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The objective of this study is to evaluate the safety and clinical usefulness of the Deep learning based Early Warning Score (DEWS).


Description:

SPTTS is the representative trigger tracking system. In addition to the conventional SPTTS, DEWS will be calculated at each time point by the previously developed algorithm. SPTTS and DEWS will be shown simulataneously on the screening board. The rapid response team performs the rescue activity as before, using both SPTTS and DEWS simultaneously. The alarm threshold setting of DEWS will be changed to 70 points, 75 points, and 80 points every month. The primary and secondary outcomes will be evaluated to compare SPTTS and DEWS (based on each threshold).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50000
Est. completion date April 30, 2022
Est. primary completion date December 30, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients admitted to general ward and monitored by in-hospital rapid response system Exclusion Criteria: - patients admitted to pediatric ward - patients in emergency room, intensive care unit, and operating room

Study Design


Intervention

Diagnostic Test:
Deep Learning Based Early Warning Score (DEWS)
DEWS use 4 vital signs (systolic blood pressure, HR, respiratory rate, and body temperature) to predict in-hospital cardiac arrest. Deep-learning approach facilitates learning the relationship between the vital signs and cardiac arrest to achieve the high sensitivity and low false-alarm rate of the track-and-trigger system (TTS).

Locations

Country Name City State
n/a

Sponsors (7)

Lead Sponsor Collaborator
Seoul National University Hospital Dong-A University, Inha University Hospital, Korea Health Industry Development Institute, Mediplex Sejong Hospital, Incheon, Sejong Hospital, Bucheon, VUNO

References & Publications (2)

Cho KJ, Kwon O, Kwon JM, Lee Y, Park H, Jeon KH, Kim KH, Park J, Oh BH. Detecting Patient Deterioration Using Artificial Intelligence in a Rapid Response System. Crit Care Med. 2020 Apr;48(4):e285-e289. doi: 10.1097/CCM.0000000000004236. — View Citation

Kwon JM, Lee Y, Lee Y, Lee S, Park J. An Algorithm Based on Deep Learning for Predicting In-Hospital Cardiac Arrest. J Am Heart Assoc. 2018 Jun 26;7(13). pii: e008678. doi: 10.1161/JAHA.118.008678. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary In-hospital cardiac arrest Compare the predictability of in-hospital cardiac arrest between DEWS and SPTTS. 3 month
Secondary Alarm coincidence Evaluate the alarm coincidence between DEWS and SPTTS. 3 month
Secondary Total alarm count. Compare the total alarm count between DEWS and SPTTS. 3 month
See also
  Status Clinical Trial Phase
Recruiting NCT02986581 - Prospective Cohort Study of Rapid Response Team
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