Trial Review

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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
Date last updated
5/05/2016

Titles & IDs
Public title
The Prevention of Failure to Rescue Using Early Warning Scoring
Scientific title
The Use of IntelliVue Patient Monitor MP5 Rel. G.1 for the Prevention of "Failure to Rescue" Using Early Warning Score
Secondary ID [1] 0 0
BUD33108
Universal Trial Number (UTN)
Trial acronym
VitalCare
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis 0 0
Renal Failure 0 0
Pulmonary Edema 0 0
Cardio-pulmonary Arrest 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survival
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Respiration Rate Impact on RRT Calls
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
* all patients admitted to the study units during the period of data collection
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* None

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2010
Sample size
Target
Accrual to date
Final
414
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Philips Healthcare
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01197326
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.
Public notes

Contacts
Principal investigator
Name 0 0
Rinaldo Bellomo, MD
Address 0 0
Faculty of Medicine, University of Melbourne, Melbourne, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01197326