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

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).

Study Overview

• Status: Terminated
• Conditions: Respiration Rate
• Intervention / Treatment: Device: INVSENSOR00004

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
  • Texas
    • Dallas, Texas, United States, 75235
      • Children's Medical Center Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INVSENSOR00004; All 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).	Device: INVSENSOR00004; The INVSENSOR00004 will be placed on the subject's neck or chest to provide acoustic respiration rate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Masimo Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2018
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: March 23, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): November 15, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: SZMU0011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No