NCT03650192

INVSENSOR00027 Clinical Performance Study

Completed NA Results posted Last updated 29 January 2021

What this trial tests

NA trial testing INVSENSOR00027 in Healthy in 40 participants. Completed in 18 September 2018.

Timeline

15 August 2018

Primary endpoint
18 September 2018

18 September 2018

Quick facts

Lead sponsor	Masimo Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	40
Start date	15 August 2018
Primary completion	18 September 2018
Estimated completion	18 September 2018
Sites	1 location across United States

Drugs / interventions tested

• INVSENSOR00027

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Masimo Corporation — full company profile →

Who can join

Adults 18 to 80, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Sensitivity of INVSENSOR00027's Posture Change Detection Primary · 1-5 hours

For each subject's position detection, INVSENSOR00027 output will be compared against observer's notes at each turn of the subject. Correctly detected position changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00027's posture change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection)

Group	Value	95% CI
INVSENSOR00027 Test Group	100

Sensitivity of INVSENSOR00027's Activity Change Detection Primary · 1-5 hours

For each subject's activity (e.g., walking and upright) detection, INVSENSOR00027 output will be compared against observer's notes. Correctly detected activity changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00027's activity change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection).

Group	Value	95% CI
INVSENSOR00027 Test Group	96.7

Sensitivity of INVSENSOR00027's Fall Event Detection Primary · 1-5 hours

Group	Value	95% CI
INVSENSOR00027 Test Group	100

Respiratory Rate Detection Secondary · 1-5 hours

Accuracy will be determined by comparing the respiratory rate measurement of the INVSENSOR00027 to the respiratory rate reference (RRef) and calculating the arithmetic root mean square (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the INVSENSOR00027 RR measurement for a number of samples. The average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms value.

Group	Value	95% CI
INVSENSOR00027 Test Group	1.7

Sponsor's own description

This study assesses the investigational sensor's (INVSENSOR00027) performance for detection of subjects' position and posture in bed, along with heart rate and respiratory rate.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.