NCT04959136

Feasibility Study Of Ambulatory Monitoring System

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 0 Days – 100 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2021-09-01
• Primary completion: 2024-08-31
• Completion: 2024-12-30
• First posted: 2021-07-13
• Last updated: 2021-07-13