Clinical trial NCT01197326: The Prevention of Failure to Rescue Using Early Warning Scoring
Official title: The Use of IntelliVue Patient Monitor MP5 Rel. G.1 for the Prevention of "Failure to Rescue" Using Early Warning Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Renal Failure
Pulmonary Edema
Cardio-pulmonary Arrest
Keywords: patient deterioration
unplanned ICU admissions
rapid response teams
Lead sponsor: Philips Healthcare
Sponsor class: INDUSTRY
First posted: 2010-09-09
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Survival
timeFrame: 6 months
Secondary outcomes:
measure: Respiration Rate Impact on RRT Calls
timeFrame: 6 months
Other outcomes:
Locations:
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
Study officials:
affiliation: Faculty of Medicine, University of Melbourne, Melbourne, Australia
name: Rinaldo Bellomo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.