Feasibility Study Of Ambulatory Monitoring System

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Patient Monitoring
• Intervention / Treatment: Device: Ambulatory Monitoring Solution

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Satu Nikander; Phone Number: + 358 40 847 0008; Email: satu.nikander@ge.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 100 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: Ambulatory Monitoring Solution; Aim is to evaluate PR; RR; NIBP, cNIBP, SpO2 and arterial blood pressure with investigational Ambulatory Monitoring Solution (AMS)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Principal Investigator: Rita Linko, Hospital District of Helsinki and Uusimaa

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2021
• Primary Completion (ANTICIPATED): August 31, 2024
• Study Completion (ANTICIPATED): December 30, 2024

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: July 1, 2021
• First Posted (ACTUAL): July 13, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 1, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 205399745

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No