NCT04951973

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

July 7, 2021

Status Verified

June 1, 2021

Enrollment Period

5 months

First QC Date

June 27, 2021

Last Update Submit

June 30, 2021

Conditions

Keywords

deep learning based early warning scorerapid response teamin-hospital cardiac arrest

Outcome Measures

Primary Outcomes (1)

  • In-hospital cardiac arrest

    Compare the predictability of in-hospital cardiac arrest between DEWS and SPTTS.

    3 month

Secondary Outcomes (2)

  • Alarm coincidence

    3 month

  • Total alarm count.

    3 month

Interventions

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).

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to general ward

You may qualify if:

  • Patients admitted to general ward and monitored by in-hospital rapid response system

You may not qualify if:

  • patients admitted to pediatric ward
  • patients in emergency room, intensive care unit, and operating room

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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):e008678. doi: 10.1161/JAHA.118.008678.

    PMID: 29945914BACKGROUND
  • 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.

    PMID: 32205618BACKGROUND
  • Cho KJ, Kim JS, Lee DH, Lee SM, Song MJ, Lim SY, Cho YJ, Jo YH, Shin Y, Lee YJ. Prospective, multicenter validation of the deep learning-based cardiac arrest risk management system for predicting in-hospital cardiac arrest or unplanned intensive care unit transfer in patients admitted to general wards. Crit Care. 2023 Sep 5;27(1):346. doi: 10.1186/s13054-023-04609-0.

Central Study Contacts

Yeon Joo Lee, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 7, 2021

Study Start

August 1, 2021

Primary Completion

December 30, 2021

Study Completion

April 30, 2022

Last Updated

July 7, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share