Trial Outcomes & Findings for The Prevention of Failure to Rescue Using Early Warning Scoring (NCT NCT01197326)
NCT ID: NCT01197326
Last Updated: 2016-05-05
Results Overview
Survival at the end of the RRT call (time when the RRT team left the patient, average duration of calls around 25 min)
Recruitment status
COMPLETED
Target enrollment
414 participants
Primary outcome timeframe
6 months
Results posted on
2016-05-05
Participant Flow
A total of 439 beds in 12 general wards in 10 hospital from five countries inthe USA, Europe and Australia.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
205
|
209
|
|
Overall Study
COMPLETED
|
205
|
209
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Prevention of Failure to Rescue Using Early Warning Scoring
Baseline characteristics by cohort
| Measure |
Group 1
n=205 Participants
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.
|
Group 2
n=209 Participants
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.
|
Total
n=414 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
82 Participants
n=93 Participants
|
73 Participants
n=4 Participants
|
155 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
123 Participants
n=93 Participants
|
136 Participants
n=4 Participants
|
259 Participants
n=27 Participants
|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 13.2 • n=93 Participants
|
70.1 years
STANDARD_DEVIATION 15.6 • n=4 Participants
|
69.3 years
STANDARD_DEVIATION 15.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=93 Participants
|
103 Participants
n=4 Participants
|
202 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=93 Participants
|
106 Participants
n=4 Participants
|
212 Participants
n=27 Participants
|
|
Region of Enrollment
Australia
|
42 participants
n=93 Participants
|
38 participants
n=4 Participants
|
80 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
124 participants
n=93 Participants
|
118 participants
n=4 Participants
|
242 participants
n=27 Participants
|
|
Region of Enrollment
Sweden
|
21 participants
n=93 Participants
|
20 participants
n=4 Participants
|
41 participants
n=27 Participants
|
|
Region of Enrollment
Netherlands
|
7 participants
n=93 Participants
|
9 participants
n=4 Participants
|
16 participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
11 participants
n=93 Participants
|
24 participants
n=4 Participants
|
35 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 monthsSurvival at the end of the RRT call (time when the RRT team left the patient, average duration of calls around 25 min)
Outcome measures
| Measure |
Group 1
n=205 Participants
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.
|
Group 2
n=209 Participants
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.
|
|---|---|---|
|
Survival
|
86 percentage of participants
|
92 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsProportion of calls secondary to abnormal respiratory vital signs. Respiration Rate is considered to be one of the main early indicators of deterioration.
Outcome measures
| Measure |
Group 1
n=205 Participants
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.
|
Group 2
n=209 Participants
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.
|
|---|---|---|
|
Respiration Rate Impact on RRT Calls
|
21 percentage of calls
|
31 percentage of calls
|
Adverse Events
Patients Who Triggered MET/RRT Calls Prior to the Use of MP5
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients Who Triggered MET/RRT Calls After the Use of MP5
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Duane A Young-Kershaw RN, BSN, Clinical Researcher
Philips Healthcare
Phone: 508-817-7001
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60