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
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Sleep Apnea
• Sleep Apnea Syndromes

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