An observational study in Severe Sepsis, Cardiac Arrest and Respiratory Failure, sponsored by Philips Healthcare. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-04.
Sponsored by Philips Healthcare · Observational
A hospitals manual method of patient monitoring will be implemented in an automated system and supported by an early patient deterioration detection for timely escalation. The purpose of this study is to assess if clinical outcomes of patients in Acute Care are significantly improved by such a system.
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.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 678 is above the median of 160 across 931 observational studies indexed under Sepsis.
Browse Sepsis studies →Philips Healthcare is the lead sponsor of 35 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The investigators 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). Study participants will be recruited from all eligible patients during the enrollment period who are having vital signs monitoring performed as Standard of Care.
Exclusion Criteria:
Patients who triggered ACT/RRT calls prior to the installation of the IGS (Intellivue Guardian System)
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
Does the IGS significantly increase positive outcomes for deteriorating patients after referral to the RRT/ACT as measured by the MAELOR score
Time frame: 15 months
Early detection of patient deterioration
Does the IGS detect patient deterioration earlier and therefore prevent or shorten periods of severe illness.
Time frame: 15 months
Daily workload for the ward's personnel
Does the IGS reduce the daily workload related to patient surveillance for the general ward personnel.
Time frame: 15 months
Level of satisfaction
Do Nurses and Doctors express a higher level of satisfaction with the IGS in place than with their current paper-based surveillance.
Time frame: 15 months
Plan to share: No
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Philips Healthcare