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Completed

NCT Number: NCT03239574

MightySat - Clinical Performance Comparison Study

This study compares the performance of respiratory rate from pleth (RRp) measured with MightySat device on healthy subjects.Subjects will be asked to breathe at specific rates ranging from 5 to 30 breaths per minute.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

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 45 years old
  • 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

  • Younger than 18 years old, older than 45 years old
  • ASA physical status of III, IV, and V
  • Subject has any medical condition which in the judgement of the investigator, renders them inappropriate for participation in the 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
  • Refusal of male subjects to agree to shave hair off areas where sensors will be applied (neck)
  • Excluded at Principal Investigator's discretion

Treatment and study plan

MightySat

Device

MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study

Primary outcomes

  1. Accuracy of RRp Determination

    Time frame: approximately 30-40 minutes

    Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the MightySat to the respiratory rate (RR) reference and calculating the arithmetic root mean square error (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the MightySat 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 Error value.

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 4, 2017
Registry last updated
Dec 31, 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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