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Completed

NCT Number: NCT03650192

INVSENSOR00027 Clinical Performance Study

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.

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Key information

Conditions

Healthy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masimo Clinical Lab

Irvine, California, 92618, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 to 80 years old
  • Physical status of ASA I or II
  • Subjects must be able to read and communicate in English
  • Has signed all necessary related documents, e.g. written informed consent, volunteer payment form, confidentiality agreement
  • Has completed Health Assessment Questionnaire and passed health assessment screening

Exclusion criteria

  • Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study
  • Inability to tolerate sitting still or minimal movement for at least 30 minutes
  • Nursing female volunteers
  • Excluded at the Principal Investigator's discretion
  • Refusal to take the pregnancy test (for female subjects)
  • Positive pregnancy test for female subjects of child bearing potential. This is done for the safety of this population.
  • Refusal to shave hair (neck, chest) off areas where sensors will be applied (male subjects)

Treatment and study plan

INVSENSOR00027

Device

Investigational, noninvasive sensor that will be placed on the subject's chest and/or back. INVSENSOR00027 measures signals regarding subject's movement and posture, heart rate, and respiratory rate.

Primary outcomes

  1. Sensitivity of INVSENSOR00027's Posture Change Detection

    Time frame: 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)

  2. Sensitivity of INVSENSOR00027's Activity Change Detection

    Time frame: 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).

  3. Sensitivity of INVSENSOR00027's Fall Event Detection

    Time frame: 1-5 hours

Secondary outcomes

  1. Respiratory Rate Detection

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 28, 2018
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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