Feasibility Study Of Ambulatory Monitoring System

Study Overview
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Brief Summary
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This is a clinical, data collection study conducted at one site. This study will collect open comments, user feedback and parameter raw data to support patient monitoring product development. Subjects participating in this study will be monitored with the site's standard of care primary monitor and the investigational device as the secondary monitor while enrolled in this study. No subject care decisions or diagnoses will be made based on information obtained from the investigational secondary monitor.

Detailed Description
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This is a pre-market, open label, prospective, non-randomized, data collection clinical research study conducted at one investigational site. This study will collect open comments, user feedback and parameter raw data to support product development. Raw parameter data will be collected from electrocardiogram (ECG), Pulse Rate (PR), respiratory rate (RR), peripheral capillary oxygen saturation (SpO2), non-invasive blood pressure (NIBP), and temperature. Subjects participating in this study will be monitored with the site's standard of care primary monitor and the investigational device as the secondary monitor while enrolled in this study. No subject care decisions or diagnoses will be made based on information obtained from the investigational secondary monitor. Participation is expected to last no more than 72 hours.

Official Title
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Feasibility Study Of Ambulatory Monitoring System

Conditions
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Patient Monitoring

Intervention / Treatment
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* Device: Ambulatory Monitoring Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are able to provide written informed consent or have a legally designated representative 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; AND Are an adult 18 years or older, or pediatric or neonate subject. Exclusion Criteria: Are known to be pregnant; Are breastfeeding; OR Are suffering from infections that require isolation.

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ambulatory Monitoring Solution<br>The evaluable device (Ambulatory Monitoring Solution and its parts) is a secondary monitoring device and no decisions/diagnosis will be made from these devices. | Device: Ambulatory Monitoring Solution<br>* Aim is to evaluate PR; RR; NIBP, cNIBP, SpO2 and arterial blood pressure with investigational Ambulatory Monitoring Solution (AMS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User feedback | This is an early feasibility study intended to elicit user feedback in a hospital setting in order to improve device functionality and further development of the measurement algorithms. User feedback will be collected by open comments field in CRF. | through study completion, average of one day per subject | 
| Collection of electronic parameter data | Electronic device files from patient sensors will be collected for each subject. | 2 hours up to 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety information | To collect safety information, including type and number of AEs, SAEs, and device issues. | through study completion and issues resolved, average of one day per subject |