The Prevention of Failure to Rescue Using Early Warning Scoring

NCT ID: NCT01197326

Last Updated: 2016-05-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

414 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sepsis Renal Failure Pulmonary Edema Cardio-pulmonary Arrest

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.

use of the MP5 EWS patient monitor

Intervention Type DEVICE

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.

use of the MP5 EWS patient monitor

Intervention Type DEVICE

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.

Interventions

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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 Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Philips Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rinaldo Bellomo, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, University of Melbourne, Melbourne, Australia

Locations

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Austin Hospital

Heidelberg, Victoria, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED
PMID: 22809908 (View on PubMed)

Other Identifiers

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BUD33108

Identifier Type: -

Identifier Source: org_study_id

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