Examination of the Impact of Better Surveillance and Communication of Patient Deterioration on Patient Related Outcomes

NCT ID: NCT01692847

Last Updated: 2016-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

678 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Severe Sepsis Cardiac Arrest Respiratory Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RRT calls prior to IGS use

Patients who triggered ACT/RRT calls prior to the installation of the IGS (Intellivue Guardian System)

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* less than 24h on ward
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Philips Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian P Subbe, MD

Role: PRINCIPAL_INVESTIGATOR

Bangor University

Locations

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Ysbyty Gwynedd Hospital

Bangor, Penrhosgarnedd, United Kingdom

Site Status

Countries

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United Kingdom

References

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Subbe CP, Duller B, Bellomo R. Effect of an automated notification system for deteriorating ward patients on clinical outcomes. Crit Care. 2017 Mar 14;21(1):52. doi: 10.1186/s13054-017-1635-z.

Reference Type DERIVED
PMID: 28288655 (View on PubMed)

Other Identifiers

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12/WA/0050

Identifier Type: OTHER

Identifier Source: secondary_id

SD-05163-BBN-IGS

Identifier Type: -

Identifier Source: org_study_id

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