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Completed

NCT Number: NCT03897179

INVSENSOR00032 and INVSENSOR00033 Respiration Rate Clinical Performance Study

This study compares the performance of respiration rate from pleth measured prospectively with either INVSENSOR00032 and/or INVSENSOR00033 devices against the respiration rate derived from the manual scoring of the capnography waveform in healthy adult subjects.

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Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masimo Corporation

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

  • Physical status of ASA I or II
  • Must be able to read and communicate in English
  • Has signed all necessary related documents, e.g. written informed consent, confidentiality agreement.
  • Passed health assessment screening
  • Negative pregnancy test for female subjects of child bearing potential.

Exclusion criteria

  • Physical status of ASA III, IV, or V
  • 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
  • Positive pregnancy test for female subjects
  • Refusal to take pregnancy test for women of child bearing potential
  • Nursing female subjects
  • Subjects wearing acrylic nails or subjects refusing to remove nail polish
  • Subjects who have a nail deformity on the measurement finger
  • Subjects who do not have adequate skin integrity on the measurement finger
  • Excluded at the Principal Investigator's discretion

Treatment and study plan

INVSENSOR00032 and INVSENSOR00033

Device

Investigational pulse oximeter device

Primary outcomes

  1. RRp Arms of Sensor Accuracy

    Time frame: 1-5 hours

    Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the INVSENSOR00032 and/or INVSENSOR00033 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 INVSENSOR00032 and/or INVSENSOR00033 RRp 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
2019
Primary completion
2019
Study completion
2019
First posted
Apr 1, 2019
Registry last updated
Mar 27, 2020

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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