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

NCT03482505 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-11-15

Study results available
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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).

Conditions

  • Respiration Rate

Interventions

DEVICE

INVSENSOR00004

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

Sponsors & Collaborators

  • Masimo Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-12
Primary Completion
2018-08-31
Completion
2018-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03482505 on ClinicalTrials.gov