MightySat - Clinical Performance Comparison Study
- Conditions
- Healthy
- Interventions
- Device: MightySat
- Registration Number
- NCT03239574
- Lead Sponsor
- Masimo Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MightySat Test group MightySat The subjects will be enrolled into the test group and will receive the MightySat investigational pulse oximeter.
- Primary Outcome Measures
Name Time Method Accuracy of RRp Determination 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Masimo Clinical Lab
🇺🇸Irvine, California, United States