Healthy
Conditions
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.
Interventions
DEVICEMightySat
MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MightySat Test Group The subjects will be enrolled into the test group and will receive the MightySat investigational pulse oximeter.
MightySat: MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | MightySat Test Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants |
| Race/Ethnicity, Customized African American | 10 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 3 Participants |
| Race/Ethnicity, Customized Caucasian | 15 Participants |
| Race/Ethnicity, Customized Hispanic | 5 Participants |
| Race/Ethnicity, Customized Middle Eastern | 1 Participants |
| Region of Enrollment United States | 34 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
Accuracy of RRp Determination
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.
Time frame: approximately 30-40 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MightySat Test Group | Accuracy of RRp Determination | 1.9 breaths per minute |