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Completed

NCT Number: NCT01197326

The Prevention of Failure to Rescue Using Early Warning Scoring

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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Key information

Conditions

Sepsis Cardio-pulmonary Arrest Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Kidney Diseases Lung Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Edema Renal Failure Renal Insufficiency Respiratory Tract Diseases Systemic Inflammatory Response Syndrome Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Austin Hospital

Heidelberg, Victoria, 3084, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

use of the MP5 EWS patient monitor

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.

Primary outcomes

  1. Survival

    Time frame: 6 months

    Survival at the end of the RRT call (time when the RRT team left the patient, average duration of calls around 25 min)

Secondary outcomes

  1. Respiration Rate Impact on RRT Calls

    Time frame: 6 months

    Proportion of calls secondary to abnormal respiratory vital signs. Respiration Rate is considered to be one of the main early indicators of deterioration.

Sponsors and collaborators

Lead sponsor

Philips Healthcare

Industry

Registry information

Official study title

The Use of IntelliVue Patient Monitor MP5 Rel. G.1 for the Prevention of "Failure to Rescue" Using Early Warning Score

Acronym: VitalCare

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 9, 2010
Registry last updated
May 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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