The Prevention of Failure to Rescue Using Early Warning Scoring

Completed

• Conditions: Sepsis; Renal Failure; Pulmonary Edema; Cardio-pulmonary Arrest
• Interventions: Device: use of the MP5 EWS patient monitor

• Registration Number: NCT01197326
• Lead Sponsor: Philips Healthcare

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.

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2010-05
• Study Completion: 2010-06
• Study First Submitted: 2010-09-03
• Study First Submitted QC: 2010-09-07
• Study First Posted: 2010-09-09
• Results First Submitted: 2012-12-17
• Results First Submitted QC: 2014-11-19
• Results First Posted: 2014-11-20
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-01
• Last Update Posted: 2016-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 414

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	use of the MP5 EWS patient monitor	Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.
Group 1	use of the MP5 EWS patient monitor	Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.

Primary Outcome Measures

Name	Time	Method
Survival	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 Outcome Measures

Name	Time	Method
Respiration Rate Impact on RRT Calls	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.

Trial Locations

Locations (1)

Austin Hospital; 🇦🇺 Heidelberg, Victoria, Australia