Back to resultsRainbow Acoustic Monitoring (RAM) in Patients Weighing up to 10kg Comparison Study
Primary Purpose
Respiration Rate
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
INVSENSOR00004
Sponsored by
About this trial
This is an interventional other trial for Respiration Rate
Eligibility Criteria
Inclusion Criteria:
- Subjects weighing up to 10kg
- Subjects will be inpatients and/or outpatients admitted to the NICU (Neonatal Intensive Care Unit) or PICU (Pediatric Intensive Care Unit) or PACU (Post-Anaesthesia Care Unit)
- The parent/legal guardian has given written informed consent/assent to participate in the study.
Exclusion Criteria:
- Subjects with underdeveloped skin
- Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, infections, abnormalities, etc.
- Subjects deemed not suitable for the study at the discretion of the investigator.
Sites / Locations
- Loma Linda University Medical Center
- Children's Medical Center Dallas
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
INVSENSOR00004
Arm Description
All enrolled subjects will receive the INVSENSOR00004 sensor. The INVSENSOR00004 rainbow acoustic monitoring (RAM) acoustic respiration sensor is designed to noninvasively convert acoustical airflow patterns into respiratory rate (RRa).
Outcomes
Primary Outcome Measures
Accuracy of Acoustic Respiration Rate (RRa)
Acoustic respiration rate (RRa) as determined by the INVSENSOR00004 will be compared to measurements of actual respiration rates as determined by manual annotation of recorded respiration waveform (RRref) data. Evaluation of the RRa measurements will be reported as bias between the RRa and the RRref.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03482505
Brief Title
Rainbow Acoustic Monitoring (RAM) in Patients Weighing up to 10kg Comparison Study
Official Title
Rainbow Acoustic Monitoring (RAM) in Patients Weighing up to 10kg Comparison Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
March 12, 2018 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 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
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The objective of this clinical investigational study is to compare the acoustic respiration rates (RRa) obtained using the INVSENSOR0004 sensor in the subjects up to 10 kg with the respiration rates determined by manual annotations (RRref), and when applicable with capnography respiration rate (RRcap).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiration Rate
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
INVSENSOR00004
Arm Type
Experimental
Arm Description
All enrolled subjects will receive the INVSENSOR00004 sensor. The INVSENSOR00004 rainbow acoustic monitoring (RAM) acoustic respiration sensor is designed to noninvasively convert acoustical airflow patterns into respiratory rate (RRa).
Intervention Type
Device
Intervention Name(s)
INVSENSOR00004
Intervention Description
The INVSENSOR00004 will be placed on the subject's neck or chest to provide acoustic respiration rate.
Primary Outcome Measure Information:
Title
Accuracy of Acoustic Respiration Rate (RRa)
Description
Acoustic respiration rate (RRa) as determined by the INVSENSOR00004 will be compared to measurements of actual respiration rates as determined by manual annotation of recorded respiration waveform (RRref) data. Evaluation of the RRa measurements will be reported as bias between the RRa and the RRref.
Time Frame
One study visit lasting up to 60 minutes.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects weighing up to 10kg
Subjects will be inpatients and/or outpatients admitted to the NICU (Neonatal Intensive Care Unit) or PICU (Pediatric Intensive Care Unit) or PACU (Post-Anaesthesia Care Unit)
The parent/legal guardian has given written informed consent/assent to participate in the study.
Exclusion Criteria:
Subjects with underdeveloped skin
Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, infections, abnormalities, etc.
Subjects deemed not suitable for the study at the discretion of the investigator.
Facility Information:
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Children's Medical Center Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Rainbow Acoustic Monitoring (RAM) in Patients Weighing up to 10kg Comparison Study
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