SepsisVitalCareNCT01197326
The Prevention of Failure to Rescue Using Early Warning Scoring
An observational study of Sepsis and Renal Failure, run by Philips Healthcare at 1 site in Australia.
Trial summary
The purpose of this study is to assess if, compared with standard paper-based systems, an automated Early Warning System (EWS) resident in a spot check patient monitor, can help to identify deteriorating patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Renal Failure, Pulmonary Edema
- What is being tested?
- use of the MP5 EWS patient monitor
- Type of treatment
- Medical device
- How many people
- 414 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2009to Jun 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: We 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). We will also enroll 1-2 pediatric units to be used as pilot data, since there is less available empiric data published in the literature. 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
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of IntelliVue Patient Monitor MP5 Rel. G.1 for the Prevention of "Failure to Rescue" Using Early Warning Score
The purpose of this study is to assess if, compared with standard paper-based systems, an automated Early Warning System (EWS) resident in a spot check patient monitor, can help to identify deteriorating patients.
Read the detailed description
The purpose of this study is to assess if, compared with standard paper-based systems, an automated Early Warning System (EWS) resident in a spot check patient monitor, can help to identify patients in the acute care settings but outside of the intensive care unit, who may be experiencing physiological instability and who are in need of rapid clinical intervention by a Rapid Response Team (RRT)/ Medical Emergency Team (MET).
The development of such an automated system by offers a unique opportunity to assess its user-friendliness, labour-saving effect, feasibility and clinical utility. Accordingly, we plan to conduct a research program aimed at assessing this new approach toward patient monitoring.
This study will use the hospital's Standard of Care protocol for the monitoring of vital signs (including timing and vital signs collected) and a commercially available automatic spot check monitor to collect data. No investigational procedures or devices are associated with this protocol.
- Conditions
- Sepsis, Renal Failure, Pulmonary Edema, Cardio-pulmonary Arrest
- Being tested
- use of the MP5 EWS patient monitor
- Keywords
- patient deterioration, unplanned ICU admissions, rapid response teams
- Medical subject headings
- Sepsis, Renal Insufficiency, Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of the MP5 EWS patient monitorDevice
All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor. Receives: Device: use of the MP5 EWS patient monitor | |
| Group 2 | Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor. Receives: Device: use of the MP5 EWS patient monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Survival at the end of the RRT call (time when the RRT team left the patient, average duration of calls around 25 min)
Measured: 6 months
Secondary outcomes (1)
Respiration Rate Impact on RRT Calls
Proportion of calls secondary to abnormal respiratory vital signs. Respiration Rate is considered to be one of the main early indicators of deterioration.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startAug 2009
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rinaldo Bellomo, MD, Principal investigator, Faculty of Medicine, University of Melbourne, Melbourne, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197326
- Sponsor's protocol ID
- BUD33108
- Acronym
- VitalCare
- Status last verified
- Apr 2016
- First submitted
- 3 Sep 2010
- Last updated
- 5 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bellomo R, Ackerman M, Bailey M, Beale R, Clancy G, Danesh V, Hvarfner A, Jimenez E, Konrad D, Lecardo M, Pattee KS, Ritchie J, Sherman K, Tangkau P; Vital Signs to Identify, Target, and Assess Level of Care Study (VITAL Care Study) Investigators. A controlled trial of electronic automated advisory vital signs monitoring in general hospital wards. Crit Care Med. 2012 Aug;40(8):2349-61. doi: 10.1097/CCM.0b013e318255d9a0.
PubMed 22809908
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of IntelliVue Patient Monitor MP5 Rel. G.1 for the Prevention of "Failure to Rescue" Using Early Warning Score
- ClinicalTrials.gov ID
- NCT01197326
- Acronym / sponsor ID
- VitalCare / BUD33108
- Conditions
- Sepsis, Renal Failure, Pulmonary Edema, Cardio-pulmonary Arrest
- Keywords
- patient deterioration, unplanned ICU admissions, rapid response teams
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- Philips HealthcareIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Posted 20 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess if, compared with standard paper-based systems, an automated Early Warning System (EWS) resident in a spot check patient monitor, can help to identify deteriorating patients.
Detailed description
The purpose of this study is to assess if, compared with standard paper-based systems, an automated Early Warning System (EWS) resident in a spot check patient monitor, can help to identify patients in the acute care settings but outside of the intensive care unit, who may be experiencing physiological instability and who are in need of rapid clinical intervention by a Rapid Response Team (RRT)/ Medical Emergency Team (MET).
The development of such an automated system by offers a unique opportunity to assess its user-friendliness, labour-saving effect, feasibility and clinical utility. Accordingly, we plan to conduct a research program aimed at assessing this new approach toward patient monitoring.
This study will use the hospital's Standard of Care protocol for the monitoring of vital signs (including timing and vital signs collected) and a commercially available automatic spot check monitor to collect data. 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 |
|---|---|---|
| Group 1 | – | Device: use of the MP5 EWS patient monitorPatients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor. |
| Group 2 | – | Device: use of the MP5 EWS patient monitorPatients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We 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). We will also enroll 1-2 pediatric units to be used as pilot data, since there is less available empiric data published in the literature. 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)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use of the MP5 EWS patient monitorAll patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device. | Device | Group 1, Group 2 |
Primary outcome
Survival
Time frame: 6 months
Survival at the end of the RRT call (time when the RRT team left the patient, average duration of calls around 25 min)
1 secondary outcome
Respiration Rate Impact on RRT Calls
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22809908Bellomo R, Ackerman M, Bailey M, Beale R, Clancy G, Danesh V, Hvarfner A, Jimenez E, Konrad D, Lecardo M, Pattee KS, Ritchie J, Sherman K, Tangkau P; Vital Signs to Identify, Target, and Assess Level of Care Study (VITAL Care Study) Investigators. A controlled trial of electronic automated advisory vital signs monitoring in general hospital wards. Crit Care Med. 2012 Aug;40(8):2349-61. doi: 10.1097/CCM.0b013e318255d9a0.
- 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.
Rinaldo Bellomo, MD principal investigator
Faculty of Medicine, University of Melbourne, Melbourne, Australia
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 Sepsis and Renal Failure, run by Philips Healthcare at 1 site in Australia.
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 5 May 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 Australia. 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?
Yes. Results are posted in the registry (first posted 20 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Survival (time frame: 6 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 NCT01197326, 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 5 May 2016.