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The Prevention of Failure to Rescue Using Early Warning Scoring (VitalCare)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01197326
First Posted: September 9, 2010
Last Update Posted: May 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Philips Healthcare
  Purpose
The purpose of this study is to assess if, compared with standard paper-based systems, an automated Early Warning System (EWS) resident in a spot check patient monitor, can help to identify deteriorating patients.

Condition Intervention
Sepsis Renal Failure Pulmonary Edema Cardio-pulmonary Arrest Device: use of the MP5 EWS patient monitor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of IntelliVue Patient Monitor MP5 Rel. G.1 for the Prevention of "Failure to Rescue" Using Early Warning Score

Further study details as provided by Philips Healthcare:

Primary Outcome Measures:
  • Survival [ Time Frame: 6 months ]
    Survival at the end of the RRT call (time when the RRT team left the patient, average duration of calls around 25 min)


Secondary Outcome Measures:
  • Respiration Rate Impact on RRT Calls [ Time Frame: 6 months ]
    Proportion of calls secondary to abnormal respiratory vital signs. Respiration Rate is considered to be one of the main early indicators of deterioration.


Enrollment: 414
Study Start Date: August 2009
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.
Device: use of the MP5 EWS patient monitor
All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device.
Group 2
Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.
Device: use of the MP5 EWS patient monitor
All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device.

Detailed Description:

The purpose of this study is to assess if, compared with standard paper-based systems, an automated Early Warning System (EWS) resident in a spot check patient monitor, can help to identify patients in the acute care settings but outside of the intensive care unit, who may be experiencing physiological instability and who are in need of rapid clinical intervention by a Rapid Response Team (RRT)/ Medical Emergency Team (MET).

The development of such an automated system by offers a unique opportunity to assess its user-friendliness, labour-saving effect, feasibility and clinical utility. Accordingly, we plan to conduct a research program aimed at assessing this new approach toward patient monitoring.

This study will use the hospital's Standard of Care protocol for the monitoring of vital signs (including timing and vital signs collected) and a commercially available automatic spot check monitor to collect data. No investigational procedures or devices are associated with this protocol.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
We plan to observe a non-probability, convenience sample of patients which will consist primarily of acutely ill hospitalized adult patients (at least 18 years of age). We will also enroll 1-2 pediatric units to be used as pilot data, since there is less available empiric data published in the literature. Study participants will be recruited from all eligible patients during the enrollment period who are having vital signs monitoring performed as Standard of Care.
Criteria

Inclusion Criteria:

  • all patients admitted to the study units during the period of data collection

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01197326


Locations
Australia, Victoria
Austin Hospital
Heidelberg, Victoria, Australia, 3084
Sponsors and Collaborators
Philips Healthcare
Investigators
Principal Investigator: Rinaldo Bellomo, MD Faculty of Medicine, University of Melbourne, Melbourne, Australia
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT01197326     History of Changes
Other Study ID Numbers: BUD33108
First Submitted: September 3, 2010
First Posted: September 9, 2010
Results First Submitted: December 17, 2012
Results First Posted: November 20, 2014
Last Update Posted: May 5, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Philips Healthcare:
patient deterioration
unplanned ICU admissions
rapid response teams

Additional relevant MeSH terms:
Renal Insufficiency
Pulmonary Edema
Heart Arrest
Apnea
Kidney Diseases
Urologic Diseases
Lung Diseases
Respiratory Tract Diseases
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms