Respiration Rate
Conditions
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).
Interventions
DEVICEINVSENSOR00004
The INVSENSOR00004 will be placed on the subject's neck or chest to provide acoustic respiration rate.
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
INVSENSOR00004: The INVSENSOR00004 will be placed on the subject's neck or chest to provide acoustic respiration rate. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | INVSENSOR00004 | — |
|---|---|---|
| Age, Categorical <=18 years | 10 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 10 participants | — |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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.
Time frame: One study visit lasting up to 60 minutes.
Population: Sufficient number of cases to meet sample size criteria for assessing outcomes was not achieved. The protocol required a minimum of 18 subjects with valid breaths to calculate the bias, precision, and ARMS of the study. This study was not able to meet this target and therefore the bias, precision, and ARMS could not be calculated (primary outcome measure).