Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Philips Healthcare
ClinicalTrials.gov Identifier:
NCT01197326
First received: September 3, 2010
Last updated: November 19, 2014
Last verified: November 2014

September 3, 2010
November 19, 2014
August 2009
May 2010   (final data collection date for primary outcome measure)
Survival [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Survival at the end of the RRT call
Does the use of the EWS monitor significantly decrease the mean duration of delay before activation a MET/RRT intervention and the proportion of calls where there is a >30 minute delay between the detection for MET/RRT call criteria and team activation? [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01197326 on ClinicalTrials.gov Archive Site
Respiration Rate Impact on RRT Calls [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Proportion of calls secondary to abnormal respiratory vital signs. Respiration Rate is considered to be one of the main early indicators of deterioration.
Do nurses feel that their current MET/RRT system is satisfactory and do they think that their current vital sign monitoring and recording system is satisfactory? [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
The Prevention of Failure to Rescue" Using Early Warning Scoring
The Use of IntelliVue Patient Monitor MP5 Rel. G.1 for the Prevention of "Failure to Rescue" Using Early Warning Score

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Sepsis
  • Renal Failure
  • Pulmonary Edema
  • Cardio-pulmonary Arrest
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 1
    Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.
    Intervention: Device: use of the MP5 EWS patient monitor
  • Group 2
    Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.
    Intervention: Device: use of the MP5 EWS patient monitor
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
414
June 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01197326
BUD33108
No
Philips Healthcare
Philips Healthcare
Not Provided
Principal Investigator: Rinaldo Bellomo, MD Faculty of Medicine, University of Melbourne, Melbourne, Australia
Philips Healthcare
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP