Cardio-pulmonary Arrest, Pulmonary Edema, Renal Failure, Sepsis
Conditions
Keywords
patient deterioration, unplanned ICU admissions, rapid response teams
Brief 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.
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.
Interventions
DEVICEuse 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.
Sponsors
Philips Healthcare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* all patients admitted to the study units during the period of data collection
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiration Rate Impact on RRT Calls | 6 months | Proportion of calls secondary to abnormal respiratory vital signs. Respiration Rate is considered to be one of the main early indicators of deterioration. |
Countries
Australia
Participant flow
Recruitment details
A total of 439 beds in 12 general wards in 10 hospital from five countries inthe USA, Europe and Australia.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 205 |
| 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. | 209 |
| Total | 414 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 123 Participants | 136 Participants | 259 Participants |
| Age, Categorical Between 18 and 65 years | 82 Participants | 73 Participants | 155 Participants |
| Age, Continuous | 68.4 years STANDARD_DEVIATION 13.2 | 70.1 years STANDARD_DEVIATION 15.6 | 69.3 years STANDARD_DEVIATION 15.9 |
| Region of Enrollment Australia | 42 participants | 38 participants | 80 participants |
| Region of Enrollment Netherlands | 7 participants | 9 participants | 16 participants |
| Region of Enrollment Sweden | 21 participants | 20 participants | 41 participants |
| Region of Enrollment United Kingdom | 11 participants | 24 participants | 35 participants |
| Region of Enrollment United States | 124 participants | 118 participants | 242 participants |
| Sex: Female, Male Female | 99 Participants | 103 Participants | 202 Participants |
| Sex: Female, Male Male | 106 Participants | 106 Participants | 212 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 205 | 0 / 209 |
| serious Total, serious adverse events | 0 / 205 | 0 / 209 |
Outcome results
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)
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Survival | 86 percentage of participants |
| Group 2 | Survival | 92 percentage of 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.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Respiration Rate Impact on RRT Calls | 21 percentage of calls |
| Group 2 | Respiration Rate Impact on RRT Calls | 31 percentage of calls |