Automated Respiration Rate to Improve Accuracy of the Electronic Cardiac Arrest Risk Triage Score (eCART) Algorithm
Automated Respiration Rate Evaluation to Improve Accuracy of the Early Warning Score Procedure Determined by the Electronic Cardiac Arrest Risk Triage Score (eCART) Algorithm
1 other identifier
observational
133
1 country
1
Brief Summary
Currently, breathing rate and heart rate are checked by nursing staff manually every few hours and entered into a patient's medical record. The investigators are doing this study to see if a device that will automatically record breathing rate and heart rate every 15 minutes is as accurate as the manual measurement. The investigators will also see if these measurements, taken every 15 minutes, will help us predict adverse events more quickly and accurately than the measurements taken every few hours.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2015
CompletedFirst Posted
Study publicly available on registry
March 26, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedMay 20, 2016
May 1, 2016
1.1 years
March 23, 2015
May 19, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
Physiological Validity
To determine whether high-frequency (Q15min) monitoring provides respiratory rates with greater physiological validity than standard manual (Q4hr) vitals.
6 months
Accuracy
To determine whether high-frequency (Q15min) monitoring provides data with greater accuracy for predicting risk of adverse events than intermittent (Q4hr) validated vitals.
6 months
Time of Detection
To determine whether high-frequency (Q15 min) monitoring of pulse and respiratory rates provides earlier detection of patient deterioration than standard validated (Q4hr) vitals or continuous respiratory monitoring (Qcont).
6 months
Secondary Outcomes (2)
Physiological Validity
6 months
Detection Performance
6 months
Interventions
This is a purely observational study - no intervention is being administered. Data is being collected from the medical record and patient monitoring devices. Participants will wear the cableless device on their chest. This is a lightweight, small device that sticks onto the skin. We will record breathing rate and respiratory rate from this device. We will also collect this information from the medical record. If a participant is placed on telemetry monitoring during the study period, we will collect information about alarm alerting patterns.
Eligibility Criteria
Data will be collected from all adult inpatients providing consent who are admitted to a 36 bed adult inpatient oncology unit at the University of Chicago.
You may qualify if:
- over 18 years
- able to provide written consent
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Chicagolead
- Philips Healthcarecollaborator
Study Sites (1)
University of Chicago
Chicago, Illinois, 60637, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2015
First Posted
March 26, 2015
Study Start
April 1, 2015
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
May 20, 2016
Record last verified: 2016-05