Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT03482505
Status:
TERMINATED
Last Update Posted:
2021-11-15
First Post:
2018-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Rainbow Acoustic Monitoring (RAM) in Patients Weighing up to 10kg Comparison Study
Sponsor:
Masimo Corporation
Organization:
Study Overview
Official Title:
Rainbow Acoustic Monitoring (RAM) in Patients Weighing up to 10kg Comparison Study
Status:
TERMINATED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: