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

Not Applicable

Terminated

• Conditions: Respiration Rate
• Interventions: Device: INVSENSOR00004

• Registration Number: NCT03482505
• Lead Sponsor: Masimo Corporation

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

Not available

Study Timeline

• Study Start: 2018-03-12
• Study First Submitted: 2018-03-23
• Study First Submitted QC: 2018-03-23
• Study First Posted: 2018-03-29
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Results First Submitted: 2021-08-25
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-15
• Last Update Submitted: 2021-10-15
• Results First Posted: 2021-11-15
• Last Update Posted: 2021-11-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
INVSENSOR00004	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).

Primary Outcome Measures

Name	Time	Method
Accuracy of Acoustic Respiration Rate (RRa)	One study visit lasting up to 60 minutes.	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.

Trial Locations

Locations (2)

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

Children's Medical Center Dallas; 🇺🇸 Dallas, Texas, United States