Rainbow Acoustic Monitoring (RAM) in Patients Weighing up to 10kg Comparison Study

Respiration Rate Clinical Trial

Official title:

Rainbow Acoustic Monitoring (RAM) in Patients Weighing up to 10kg Comparison Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03482505
• Other study ID #: SZMU0011
• Status: Terminated
• Phase: N/A
• Start date: March 12, 2018
• Est. completion date: August 31, 2018

Study information

• Verified date: October 2021
• Source: Masimo Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Respiration Rate

Intervention

Device:
• INVSENSOR00004
The INVSENSOR00004 will be placed on the subject's neck or chest to provide acoustic respiration rate.

Locations

Country	Name	City	State
United States	Children's Medical Center Dallas	Dallas	Texas
United States	Loma Linda University Medical Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.