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

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.

Study Overview

• Status: Completed
• Conditions: Heart Arrest
• Intervention / Treatment: Other: Respiratory & Heart Rate Data Collection

Detailed Description

Both cardiac arrest and sepsis are primarily identified by vital sign abnormalities. However, the practice of nurses and their designees routinely checking hospitalized patients' vital signs every four to eight hours throughout the day and night has remained essentially unchanged for over one hundred years. While respiratory rate has been shown to be the most predictive vital sign for adverse events on the wards, it is often inaccurately measured and poorly documented. For example, a disproportionate amount of respiratory rates are recorded as either 18 or 20 breaths/min, which is often higher than actual rates.

We have previously statistically derived a physiology-based early warning score, called the electronic cardiac arrest risk triage score (eCART), using vital signs and lab values. The eCART was more accurate than scores commonly used in hospitals today. However, the vital sign values utilized for our score were manually collected by nursing staff every four hours. Recent technological advances have allowed for high-frequency measurement of pulse and respiratory rate using a cableless respiration monitor. These devices allow for more frequent and potentially more accurate measures of respiration, which may enhance the prediction ability for detecting adverse events on the wards. In addition, the increase in monitoring frequency may result in earlier detection of adverse events, which could translate into further improvements in patient outcomes.

A subset of patients may be continuously measured using a telemetry system. The alarms and ECGs from these patients are monitored by staff in a centralized station in the hospital. When a clinical event requiring action is observed, a call is made to the unit alerting the clinical staff that action is necessary. We will collect the continuous measurements collected from this system and compare these continuous measurements to the high frequency and manual measurements.

• Study Type: Observational
• Enrollment (Actual): 133

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University Of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• over 18 years
• able to provide written consent

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological Validity	To determine whether high-frequency (Q15min) respiration monitoring provides equivalent detection performance than continuous respiratory monitoring (Qcont) as well as manual spot check measurement (Q4hr)	6 months
Detection Performance	To determine whether high-frequency (Q15min) respiratory rate monitoring provides a higher true positive rate for a given false positive rate than continuous respiratory monitoring (Qcont) as well as manual spot check measurement (Q4hr).	6 months

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: Philips Healthcare

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: March 23, 2015
• First Submitted That Met QC Criteria: March 25, 2015
• First Posted (Estimate): March 26, 2015

Study Record Updates

• Last Update Posted (Estimate): May 20, 2016
• Last Update Submitted That Met QC Criteria: May 19, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: IRB14-0682