Feasibility Study Of Ambulatory Monitoring System

NCT ID: NCT04959136

Last Updated: 2021-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2024-12-30

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.

Conditions

Patient Monitoring

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ambulatory Monitoring Solution

Intervention Type: DEVICE

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

Interventions

Ambulatory Monitoring Solution

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rita Linko

Role: PRINCIPAL_INVESTIGATOR

Hospital District of Helsinki and Uusimaa

Central Contacts

Satu Nikander

Role: CONTACT

satu.nikander@ge.com

+ 358 40 847 0008

Other Identifiers

205399745

Identifier Type: -

Identifier Source: org_study_id