The Prevention of Failure to Rescue Using Early Warning Scoring

Sepsis Clinical Trial

— VitalCare  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197326
• Other study ID #: BUD33108
• Status: Completed
• Phase: N/A
• First received: September 3, 2010
• Last updated: October 20, 2015
• Start date: August 2009
• Est. completion date: June 2010

Study information

• Verified date: October 2015
• Source: Philips Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 414
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Cardio-pulmonary Arrest
• Heart Arrest
• Pulmonary Edema
• Renal Failure
• Sepsis

Intervention

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.

Locations

Country	Name	City	State
Australia	Austin Hospital	Heidelberg	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Philips Healthcare

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Survival at the end of the RRT call (time when the RRT team left the patient, average duration of calls around 25 min)	6 months	Yes
Secondary	Respiration Rate Impact on RRT Calls	Proportion of calls secondary to abnormal respiratory vital signs. Respiration Rate is considered to be one of the main early indicators of deterioration.	6 months	Yes