Portrait Mobile Monitoring Solution V2.0 External Evaluation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous Monitoring.
- Who it may be relevant to
- Registry conditions: Monitoring. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Device Continuous Monitoring
Subjects will have vital signs continuously monitored for up to 72 hours with the study device
Primary outcome measures
- Collection of user feedback surveys from Clinicians [Time frame: Up to 72 hours]
- Collection of Subject Survey [Time frame: up to 72 hours]
Secondary outcome measures (1)
- Collection of raw parameter data from Portrait Mobile Device [Time frame: up to 72 hours]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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).
- Subjects with Implantable Minute Ventilation Rate Responsive Pacemakers should be excluded from respiration rate monitoring.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United Kingdom · 1 center
- West Middlesex University Hospital — London
Identifiers
NCT: NCT07309809 · SA-000173