Feasibility Study Of Ambulatory Monitoring System

NCT04959136 | Unknown

• 1 other identifier: 205399745
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Patient Monitoring

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Safety information

  through study completion and issues resolved, average of one day per subject

Study Arms (1)

Ambulatory Monitoring Solution

EXPERIMENTAL

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

Interventions

Ambulatory Monitoring Solution DEVICE

Aim is to evaluate PR; RR; NIBP, cNIBP, SpO2 and arterial blood pressure with investigational Ambulatory Monitoring Solution (AMS)

Ambulatory Monitoring Solution

Eligibility Criteria

• Age: 0 Days - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Are known to be pregnant;
• Are breastfeeding; OR
• Are suffering from infections that require isolation.

Sponsors & Collaborators

• GE Healthcare: lead

Study Officials

• Rita Linko

  Hospital District of Helsinki and Uusimaa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Satu Nikander

CONTACT

+ 358 40 847 0008; satu.nikander@ge.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: July 13, 2021
• Study Start: September 1, 2021
• Primary Completion: August 31, 2024
• Study Completion: December 30, 2024
• Last Updated: July 13, 2021

Record last verified: 2021-07