Rainbow Acoustic Monitoring (RAM) Clinical Engineering Data Collection

Not Applicable

Terminated

• Conditions: Sleep Apnea
• Interventions: Device: RAM sensor

• Registration Number: NCT03120897
• Lead Sponsor: Masimo Corporation

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-04-14
• Study First Posted: 2017-04-19
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2021-04
• Last Update Submitted: 2021-05-17
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 78

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test group	RAM sensor	The subjects will be enrolled into the test group and will receive RAM sensor.

Primary Outcome Measures

Name	Time	Method
Number of subjects in which respiratory rate is collected	Duration of surgery	Capture high resolution waveform data and numerical data from respiratory rate using RAM sensor

Trial Locations

Locations (1)

Stanford University Medical Center; 🇺🇸 Stanford, California, United States