An observational study in Sepsis, Renal Failure and Pulmonary Edema, sponsored by Philips Healthcare. Completed at 1 site in Australia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-05.
Sponsored by Philips Healthcare · Observational
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.
138 studies on the registry are indexed under Pulmonary Edema; 24 are open to participants now.
This study's enrollment of 414 is above the median of 118 across 57 observational studies indexed under Pulmonary Edema.
Browse Pulmonary Edema studies →Philips Healthcare is the lead sponsor of 35 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.
Device: use of the MP5 EWS patient monitor
Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.
Device: use of the MP5 EWS patient monitor
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.
Survival
Survival at the end of the RRT call (time when the RRT team left the patient, average duration of calls around 25 min)
Time frame: 6 months
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.
Time frame: 6 months
A total of 439 beds in 12 general wards in 10 hospital from five countries inthe USA, Europe and Australia.
| Milestone | Group 1 | Group 2 |
|---|---|---|
| Started | 205 | 209 |
| Completed | 205 | 209 |
| Not completed | 0 | 0 |
Survival at the end of the RRT call (time when the RRT team left the patient, average duration of calls around 25 min)
| percentage of participants | Group 1 | Group 2 |
|---|---|---|
| Survival | 86 | 92 |
Proportion of calls secondary to abnormal respiratory vital signs. Respiration Rate is considered to be one of the main early indicators of deterioration.
| percentage of calls | Group 1 | Group 2 |
|---|---|---|
| Respiration Rate Impact on RRT Calls | 21 | 31 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients Who Triggered MET/RRT Calls Prior to the Use of MP5 | — | 0/205 (0%) | 0/205 (0%) |
| Patients Who Triggered MET/RRT Calls After the Use of MP5 | — | 0/209 (0%) | 0/209 (0%) |
| Age, Categorical(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 82 | 73 | 155 |
| >=65 years | 123 | 136 | 259 |
| Age, Continuous(years) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Mean | 68.4 ± 13.2 | 70.1 ± 15.6 | 69.3 ± 15.9 |
| Sex: Female, Male(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Female | 99 | 103 | 202 |
| Male | 106 | 106 | 212 |
| Region of Enrollment(participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Australia | 42 | 38 | 80 |
| United States | 124 | 118 | 242 |
| Sweden | 21 | 20 | 41 |
| Netherlands | 7 | 9 | 16 |
| United Kingdom | 11 | 24 | 35 |
Plan to share: No
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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