Back to resultsRainbow Acoustic Monitoring (RAM) Clinical Engineering Data Collection
Primary Purpose
Sleep Apnea
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RAM sensor
Sponsored by
About this trial
This is an interventional device feasibility trial for Sleep Apnea
Eligibility Criteria
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
Sites / Locations
- Stanford University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Test group
Arm Description
The subjects will be enrolled into the test group and will receive RAM sensor.
Outcomes
Primary Outcome Measures
Number of subjects in which respiratory rate is collected
Capture high resolution waveform data and numerical data from respiratory rate using RAM sensor
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03120897
Brief Title
Rainbow Acoustic Monitoring (RAM) Clinical Engineering Data Collection
Official Title
Rainbow Acoustic Monitoring (RAM) Clinical Engineering Data Collection
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision to terminate study.
Study Start Date
June 2016 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masimo Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test group
Arm Type
Experimental
Arm Description
The subjects will be enrolled into the test group and will receive RAM sensor.
Intervention Type
Device
Intervention Name(s)
RAM sensor
Intervention Description
Rainbow Acoustic Monitoring sensor for measurement of respiratory rate
Primary Outcome Measure Information:
Title
Number of subjects in which respiratory rate is collected
Description
Capture high resolution waveform data and numerical data from respiratory rate using RAM sensor
Time Frame
Duration of surgery
10. Eligibility
Sex
All
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Rainbow Acoustic Monitoring (RAM) Clinical Engineering Data Collection
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