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
  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

Resource links provided by NLM:


Further study details as provided by Philips Healthcare:

Primary Outcome Measures:
  • Survival [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Survival at the end of the RRT call


Secondary Outcome Measures:
  • 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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Philips Healthcare

Additional 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
Study First Received: September 3, 2010
Results First Received: December 17, 2012
Last Updated: November 19, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 20, 2014