Feasibility Study Of Ambulatory Monitoring System

Patient Monitoring Clinical Trial

Official title: Feasibility Study Of Ambulatory Monitoring System

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Patient Monitoring

• NCT number: NCT04959136
• Study type: Interventional
• Source: GE Healthcare
• Contact: Satu Nikander
• Phone: + 358 40 847 0008
• Email: satu.nikander@ge.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2021
• Completion date: December 30, 2024