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

Respiratory Failure Clinical Trial

Official title:

Examination of the Impact of Better Surveillance and Communication of Patient Deterioration on Patient Related Outcomes (VitalCare - Guardian Version 2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01692847
• Other study ID #: SD-05163-BBN-IGS
• Secondary ID: 12/WA/0050
• Status: Completed
• Phase: N/A
• First received: September 21, 2012
• Last updated: April 1, 2016
• Start date: October 2012
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: Philips Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 678
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• 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:

• less than 24h on ward

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Respiratory Failure
• Respiratory Insufficiency
• Severe Sepsis

Locations

Country	Name	City	State
United Kingdom	Ysbyty Gwynedd Hospital	Bangor	Penrhosgarnedd

Sponsors (1)

Lead Sponsor	Collaborator
Philips Healthcare

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	15 months	Yes
Secondary	Early detection of patient deterioration	Does the IGS detect patient deterioration earlier and therefore prevent or shorten periods of severe illness.	15 months	Yes
Secondary	Daily workload for the ward's personnel	Does the IGS reduce the daily workload related to patient surveillance for the general ward personnel.	15 months	No
Secondary	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.	15 months	No