Portrait Mobile Monitoring Solution V2.0 External Evaluation
ConditionMonitoring
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGE Healthcare
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant is age 18 years or older (≥18 years).
Participant must have the ability to understand and provide written informed consent.
Are being cared for in a hospital unit and are expected to remain in the unit for the duration of the study procedure.
Participant must be willing and able to comply with study procedures and duration.
Disqualifiers
Known to be pregnant and/or breast feeding.
Diagnosed with infection requiring isolation.
Are immunocompromised.
Have previously participated in this study (no subject may participate more than once).
Trial design
Design model
Single group
Treatments tested in this trial
Continuous Monitoring
DeviceSubjects will have vital signs continuously monitored for up to 72 hours with the study device
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Continuous Monitoring with Portrait MobileExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 72 hours2
Collection of Subject Survey
Number of subject surveys collected from study participants at the end of their continuous monitoring
Time frame
up to 72 hoursSecondary outcomes
1
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.
Time frame
up to 72 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: