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NCT03120897 Clinical Trial

Rainbow Acoustic Monitoring (RAM) Clinical Engineering Data Collection

Sleep Apnea Clinical Trial

Official title:
Rainbow Acoustic Monitoring (RAM) Clinical Engineering Data Collection

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03120897
Other study ID # DROV0008
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date October 2018

Study information
Verified date April 2021
Source Masimo Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To capture high resolution waveform data and numerical data from investigational and FDA-released RAM sensors in the neonatal, infant, pediatric, and adult patient population

Recruitment information / eligibility
Status Terminated
Enrollment 78
Est. completion date October 2018
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender All
Age group N/A to 70 Years
Eligibility Inclusion Criteria: - Male or Female subjects that are between 0 to 70 years old. - Neonate, Infant, Pediatric, Adult, and Pregnant subjects with fully developed skin. Exclusion Criteria: - Patients with skin abnormalities at the planned application sites that would interfere with sensor, cannula or electrode applications. - Patients with pre-existing conditions and/or co-morbidities that would prohibit them from participating in the study due to unacceptable risks to their health and well-being, as determined by the Principal Investigator (PI). - Patients who the PI deems ineligible at the PI's discretion

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• RAM sensor
Rainbow Acoustic Monitoring sensor for measurement of respiratory rate

Locations
Country Name City State
United States Stanford University Medical Center Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of subjects in which respiratory rate is collected Capture high resolution waveform data and numerical data from respiratory rate using RAM sensor Duration of surgery
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