Monitoring
Conditions
Keywords
Continuous Monitoring
Brief summary
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.
Detailed description
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.
Interventions
DEVICEContinuous Monitoring
Subjects will have vital signs continuously monitored for up to 72 hours with the study device
Sponsors
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant is age 18 years or older (≥18 years). 2. Participant must have the ability to understand and provide written informed consent. 3. Are being cared for in a hospital unit and are expected to remain in the unit for the duration of the study procedure. 4. Participant must be willing and able to comply with study procedures and duration.
Exclusion criteria
1. Known to be pregnant and/or breast feeding. 2. Diagnosed with infection requiring isolation. 3. Are immunocompromised. 4. Have previously participated in this study (no subject may participate more than once). 5. Subjects with Implantable Minute Ventilation Rate Responsive Pacemakers should be excluded from respiration rate monitoring.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collection of user feedback surveys from Clinicians | Up to 72 hours | Number of clinician feedback surveys collected at the end of each shift for clinicians overseeing care of subjects receiving continuous vital signs monitoring. |
| Collection of Subject Survey | up to 72 hours | Number of subject surveys collected from study participants at the end of their continuous monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Collection of raw parameter data from Portrait Mobile Device | up to 72 hours | Collection of electronic waveforms and device logs from the investigational device for the entire monitoring period for each subject. |
Countries
United Kingdom
Contacts
CONTACTMeghan Terry
Outcome results
None listed