Severe SepsisNCT01692847
Examination of the Impact of Better Surveillance and Communication of Patient Deterioration on Patient Related Outcomes
An observational study of Severe Sepsis and Cardiac Arrest, run by Philips Healthcare at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis, Cardiac Arrest, Respiratory Failure
- How many people
- 678 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2012to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- all patients admitted to the study units during the period of data collection
Who cannot join
- less than 24h on ward
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Ysbyty Gwynedd Hospital
Bangor, Penrhosgarnedd, LL572PW
About this study
Official title: Examination of the Impact of Better Surveillance and Communication of Patient Deterioration on Patient Related Outcomes (VitalCare - Guardian Version 2)
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.
Read the detailed 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.
- Conditions
- Severe Sepsis, Cardiac Arrest, Respiratory Failure
- Keywords
- patient deterioration, rapid response teams, acute care teams, early warning scoring
- Medical subject headings
- Sepsis, Heart Arrest, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 months
Secondary outcomes (3)
Early detection of patient deterioration
Does the IGS detect patient deterioration earlier and therefore prevent or shorten periods of severe illness.
Measured: 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.
Measured: 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.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 678 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian P Subbe, MD, Principal investigator, Bangor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692847
- Sponsor's protocol ID
- SD-05163-BBN-IGS
- Other IDs
- 12/WA/0050
- Status last verified
- Apr 2016
- First submitted
- 21 Sep 2012
- Last updated
- 4 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28288655
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Impact of Better Surveillance and Communication of Patient Deterioration on Patient Related Outcomes (VitalCare - Guardian Version 2)
- ClinicalTrials.gov ID
- NCT01692847
- Acronym / sponsor ID
- SD-05163-BBN-IGS
- Conditions
- Severe Sepsis, Cardiac Arrest, Respiratory Failure
- Keywords
- patient deterioration, rapid response teams, acute care teams, early warning scoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 678 participants (actual)
- Lead sponsor
- Philips HealthcareIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- all patients admitted to the study units during the period of data collection
Key exclusion criteria (1 listed)
- less than 24h on ward
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Early detection of patient deterioration
Time frame: 15 months
Daily workload for the ward's personnel
Time frame: 15 months
Level of satisfaction
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
- Derived from this study: PubMed 28288655Subbe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian P Subbe, MD principal investigator
Bangor University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Sepsis and Cardiac Arrest, run by Philips Healthcare at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of outcome for patients after implementing the IGS (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01692847, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2016; AzTrials last refreshed its copy on 8 Nov 2026.