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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor. |
| |
| Group 2 | Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| use of the MP5 EWS patient monitor | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Survival at the end of the RRT call (time when the RRT team left the patient, average duration of calls around 25 min) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Rinaldo Bellomo, MD | Faculty of Medicine, University of Melbourne, Melbourne, Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin Hospital | Heidelberg | Victoria | 3084 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22809908 | Derived | 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. |
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A total of 439 beds in 12 general wards in 10 hospital from five countries inthe USA, Europe and Australia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor. Use the MP5 EWS monitor to measure routine vital signs : 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. |
| FG001 | Group 2 | Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor. Use the MP5 EWS monitor to measure routine vital signs : 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor. Use the MP5 EWS monitor to measure routine vital signs : 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Survival | Survival at the end of the RRT call (time when the RRT team left the patient, average duration of calls around 25 min) | Posted | Number | percentage of participants | 6 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Who Triggered MET/RRT Calls Prior to the Use of MP5 | Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Duane A Young-Kershaw RN, BSN, Clinical Researcher | Philips Healthcare | 508-817-7001 | duane.young-kershaw@philips.com |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D051437 | Renal Insufficiency |
| D011654 | Pulmonary Edema |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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|
| BG001 | Group 2 | Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor. Use the MP5 EWS monitor to measure routine vital signs : 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | Posted | Number | percentage of calls | 6 months |
|
|
|
| 0 |
| 205 |
| 0 |
| 205 |
| EG001 | Patients Who Triggered MET/RRT Calls After the Use of MP5 | Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor | 0 | 209 | 0 | 209 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |