Status:
TERMINATED
Rainbow Acoustic Monitoring (RAM) in Patients Weighing up to 10kg Comparison Study
Lead Sponsor:
Masimo Corporation
Conditions:
Respiration Rate
Eligibility:
All Genders
Phase:
NA
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 d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03482505
Start Date
March 12 2018
End Date
August 31 2018
Last Update
November 15 2021
Active Locations (2)
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1
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
2
Children's Medical Center Dallas
Dallas, Texas, United States, 75235