Examination of the Impact of Better Surveillance and Communication of Patient Deterioration on Patient Related Outcomes
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|ClinicalTrials.gov Identifier: NCT01692847|
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : April 4, 2016
|Condition or disease|
|Severe Sepsis Cardiac Arrest Respiratory Failure|
The purpose of this study is to assess if the Philips IntelliVue Guardian Solution (IGS) with all its components can significantly improve clinical outcomes for deteriorating patients on a general medical ward prior and after referral to the hospitals' Acute Care Team (ACT). Further, to provide evidence that the Philips IGS assists to increase the efficiency of a hospital's Early Warning Scoring process (afferent and efferent arm of the escalation system).
The introduction of such an intelligent automated system offers a unique opportunity to address the breakdown in the chain of prevention by strengthening the reliability of calls-for-help to responders through a technical solution with the potential for a more timely escalation where appropriate.
In this study the hospital's Standard of Care protocol for the monitoring of vital signs (including timing, vital signs collected and escalation instructions) will be implemented in a commercially available intelligent automatic monitoring and notification system. No investigational procedures or devices are associated with this protocol.
|Study Type :||Observational|
|Actual Enrollment :||678 participants|
|Official Title:||Examination of the Impact of Better Surveillance and Communication of Patient Deterioration on Patient Related Outcomes (VitalCare - Guardian Version 2)|
|Study Start Date :||October 2012|
|Primary Completion Date :||February 2016|
|Study Completion Date :||February 2016|
RRT calls prior to IGS use
Patients who triggered ACT/RRT calls prior to the installation of the IGS (Intellivue Guardian System)
RRT calls during IGS use
Patients who triggered ACT/RRT calls after the installation of IGS. All patients on the study ward receive the same care in both groups. The only difference is the system used to collect vital signs and to inform the staff about patient deteriorations. In Group 2, the IGS (FDA approved and CE marked) is the vital signs collection and information system.
- Improvement of outcome for patients after implementing the IGS [ Time Frame: 15 months ]Does the IGS significantly increase positive outcomes for deteriorating patients after referral to the RRT/ACT as measured by the MAELOR score
- Early detection of patient deterioration [ Time Frame: 15 months ]Does the IGS detect patient deterioration earlier and therefore prevent or shorten periods of severe illness.
- Daily workload for the ward's personnel [ Time Frame: 15 months ]Does the IGS reduce the daily workload related to patient surveillance for the general ward personnel.
- Level of satisfaction [ Time Frame: 15 months ]Do Nurses and Doctors express a higher level of satisfaction with the IGS in place than with their current paper-based surveillance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01692847
|Ysbyty Gwynedd Hospital|
|Bangor, Penrhosgarnedd, United Kingdom, LL572PW|
|Principal Investigator:||Christian P Subbe, MD||Bangor University|