Feasibility Study Of Ambulatory Monitoring System

Not Applicable

Not yet recruiting

• Conditions: Patient Monitoring
• Interventions: Device: Ambulatory Monitoring Solution

• Registration Number: NCT04959136
• Lead Sponsor: GE Healthcare

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-05-05
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-01
• Last Update Submitted: 2021-07-01
• Study First Posted: 2021-07-13
• Last Update Posted: 2021-07-13
• Study Start: 2021-09-01
• Primary Completion: 2024-08-31
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
User feedback	through study completion, average of one day per subject	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.
Collection of electronic parameter data	2 hours up to 3 days	Electronic device files from patient sensors will be collected for each subject.

Secondary Outcome Measures

Name	Time	Method
Safety information	through study completion and issues resolved, average of one day per subject	To collect safety information, including type and number of AEs, SAEs, and device issues.