Rainbow Acoustic Monitoring (RAM) Clinical Engineering Data Collection

Masimo

Status: Terminated

Conditions: Sleep Apnea

Treatments: Device: RAM sensor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03120897

DROV0008

Details and patient eligibility

About

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

Enrollment: 78 patients

Sex: All

Ages: Under 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

Test group

Experimental group

Description:

The subjects will be enrolled into the test group and will receive RAM sensor.

Treatment:

Device: RAM sensor