Feasibility Study Of Ambulatory Monitoring System

General Electric (GE)

Status: Not yet enrolling

Conditions: Patient Monitoring

Treatments: Device: Ambulatory Monitoring Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT04959136

205399745

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: Under 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Are able to provide written informed consent or have a legally designated representative provide written informed consent;
2. Are being cared for in a hospital unit and are expected to remain in the unit for the duration of the study procedure; AND
3. Are an adult 18 years or older, or pediatric or neonate subject.

Exclusion criteria

1. Are known to be pregnant;
2. Are breastfeeding; OR
3. Are suffering from infections that require isolation.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Ambulatory Monitoring Solution

Experimental group

Description:

The evaluable device (Ambulatory Monitoring Solution and its parts) is a secondary monitoring device and no decisions/diagnosis will be made from these devices.

Treatment:

Device: Ambulatory Monitoring Solution