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The purpose of this study is to collect and assess feedback from the users regarding the functionality and performance of the Portrait Mobile Monitoring Solution V2.0. In addition, this study aims to collect raw parameter data from the investigational devices for use in current and future Portrait Mobile development, including engineering purposes as deemed appropriate by the Sponsor.
Subjects will be enrolled from a general hospital ward to receive continuous monitoring for up to 72 hours by the Portrait Mobile Monitoring Solution V2.0. After the completion of that monitoring, both the clinician and the subject will complete a feedback survey about their experience with the device. The surveys along with raw data from the device will be collected from each subject.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Monitoring with Portrait Mobile | Experimental | Subjects will be monitored with the Portrait Mobile Monitoring Solution for up to 72 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Monitoring | Device | Subjects will have vital signs continuously monitored for up to 72 hours with the study device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Collection of user feedback surveys from Clinicians | Number of clinician feedback surveys collected at the end of each shift for clinicians overseeing care of subjects receiving continuous vital signs monitoring. | Up to 72 hours |
| Collection of Subject Survey | Number of subject surveys collected from study participants at the end of their continuous monitoring | up to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Collection of raw parameter data from Portrait Mobile Device | Collection of electronic waveforms and device logs from the investigational device for the entire monitoring period for each subject. | up to 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meghan Terry | Contact | 262-290-6037 | Meghan.Terry@gehealthcare.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Middlesex University Hospital | London | England | TW7 6AF | United Kingdom |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |