Study Stopped
Sponsor decision
Rainbow Acoustic Monitoring (RAM) in Patients Weighing up to 10kg Comparison Study
1 other identifier
interventional
10
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 12, 2018
CompletedFirst Submitted
Initial submission to the registry
March 23, 2018
CompletedFirst Posted
Study publicly available on registry
March 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2018
CompletedResults Posted
Study results publicly available
November 15, 2021
CompletedNovember 15, 2021
October 1, 2021
6 months
March 23, 2018
August 25, 2021
October 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
One study visit lasting up to 60 minutes.
Study Arms (1)
INVSENSOR00004
EXPERIMENTALAll 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).
Interventions
The INVSENSOR00004 will be placed on the subject's neck or chest to provide acoustic respiration rate.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Children's Medical Center Dallas
Dallas, Texas, 75235, United States
Results Point of Contact
- Title
- Cristina Johnson
- Organization
- Masimo
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2018
First Posted
March 29, 2018
Study Start
March 12, 2018
Primary Completion
August 31, 2018
Study Completion
August 31, 2018
Last Updated
November 15, 2021
Results First Posted
November 15, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share