Rainbow Acoustic Monitoring (RAM) Clinical Engineering Data Collection

NCT03120897 | Terminated FDA Device

• 1 other identifier: DROV0008
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Test group

EXPERIMENTAL

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

Device: RAM sensor

Interventions

RAM sensor DEVICE

Rainbow Acoustic Monitoring sensor for measurement of respiratory rate

Test group

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female subjects that are between 0 to 70 years old.
• Neonate, Infant, Pediatric, Adult, and Pregnant subjects with fully developed skin.

You may not qualify if:

• 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

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 19, 2017
• Study Start: June 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: May 18, 2021

Record last verified: 2021-04

Locations

US (1)