Feasibility Study Of Ambulatory Monitoring System

Patient Monitoring Clinical Trial

Official title:

Feasibility Study Of Ambulatory Monitoring System

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04959136
• Other study ID #: 205399745
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: July 2021
• Source: GE Healthcare
• Contact: Satu Nikander
• Phone: + 358 40 847 0008
• Email: satu.nikander[@]ge.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Patient Monitoring

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Collection of electronic parameter data	Electronic device files from patient sensors will be collected for each subject.	2 hours up to 3 days
Secondary	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