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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01197326
Registration number
NCT01197326
Ethics application status
Date submitted
3/09/2010
Date registered
9/09/2010
Titles & IDs
Public title
The Prevention of Failure to Rescue Using Early Warning Scoring
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Scientific title
The Use of IntelliVue Patient Monitor MP5 Rel. G.1 for the Prevention of "Failure to Rescue" Using Early Warning Score
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Secondary ID [1]
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BUD33108
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Universal Trial Number (UTN)
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Trial acronym
VitalCare
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sepsis
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0
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Renal Failure
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0
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Pulmonary Edema
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0
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Cardio-pulmonary Arrest
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0
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Condition category
Condition code
Respiratory
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0
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Other respiratory disorders / diseases
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Cardiovascular
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0
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0
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Coronary heart disease
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Cardiovascular
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0
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - use of the MP5 EWS patient monitor
Group 1 - Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.
Group 2 - Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.
Treatment: Devices: 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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Survival
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Assessment method [1]
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Survival at the end of the RRT call (time when the RRT team left the patient, average duration of calls around 25 min)
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Timepoint [1]
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6 months
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Secondary outcome [1]
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Respiration Rate Impact on RRT Calls
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Assessment method [1]
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Proportion of calls secondary to abnormal respiratory vital signs. Respiration Rate is considered to be one of the main early indicators of deterioration.
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Timepoint [1]
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6 months
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Eligibility
Key inclusion criteria
* all patients admitted to the study units during the period of data collection
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* None
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2010
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Sample size
Target
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Accrual to date
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Final
414
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
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3084 - Heidelberg
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Philips Healthcare
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT01197326
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Trial related presentations / publications
Bellomo R, Ackerman M, Bailey M, Beale R, Clancy G, Danesh V, Hvarfner A, Jimenez E, Konrad D, Lecardo M, Pattee KS, Ritchie J, Sherman K, Tangkau P; Vital Signs to Identify, Target, and Assess Level of Care Study (VITAL Care Study) Investigators. A controlled trial of electronic automated advisory vital signs monitoring in general hospital wards. Crit Care Med. 2012 Aug;40(8):2349-61. doi: 10.1097/CCM.0b013e318255d9a0.
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Public notes
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Contacts
Principal investigator
Name
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Rinaldo Bellomo, MD
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Address
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Faculty of Medicine, University of Melbourne, Melbourne, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01197326