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

Masimo

Status: Terminated

Conditions: Respiration Rate

Treatments: Device: INVSENSOR00004

Study type: Interventional

Funder types: Industry

Identifiers

NCT03482505

SZMU0011

Details and patient eligibility

About

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).

Enrollment: 10 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

INVSENSOR00004

Experimental group

Description:

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).

Treatment:

Device: INVSENSOR00004