Oxygen Deficiency
Conditions
Brief summary
Testing the absolute accuracy of the Masimo O3 regional oximeter in reading somatic tissue oxygenation in healthy volunteers under controlled hypoxia.
Interventions
DEVICEMasimo O3 Regional Oximeter
Study sensors will be placed on somatic tissues. Readings will be taken from the tissues underneath the O3 sensors.
Sponsors
University Medical Center Groningen
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
* Age between 18 and 45 years, inclusive * Willing and able to provide written informed consent * Healthy subjects
Exclusion criteria
* Pregnant women * Presence of any cardiovascular or pulmonary disease * Exposure to high altitude(s) (\>2000 m) within 30 days prior to the study * Known allergy to intravenous contrast medium or heparin * Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent monitoring of SpO2 levels during the study * Patients deemed not suitable for the study at the discretion of the Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of O3 Sensor by ARMS Calculation of Percent rSO2 | 1 visit up to 8 hours | Accuracy of the sensors will be determined by comparing somatic regional oxygen saturation (rSO2) readings from the O3 sensor and blood reference oxygen saturation values and calculating the Arithmetic root mean square (ARMS). |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Adult Volunteers Controlled hypoxia will be induced and Masimo O3 regional oximeter-derived rSO2 readings of somatic tissue will be measured. The readings will be compared with blood reference oxygen saturation values.
Masimo O3 Regional Oximeter: Study sensors will be placed on somatic tissues. Readings will be taken from the tissues underneath the O3 sensors. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Physician Decision | 8 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Healthy Adult Volunteers | — |
|---|---|---|
| Age, Customized 18 to 45 years of age | 25 Participants | — |
| Age, Customized < 18 years of age | 0 Participants | — |
| Age, Customized > 45 years of age | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 16 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 37 |
| other Total, other adverse events | 17 / 37 |
| serious Total, serious adverse events | 1 / 37 |
Outcome results
Primary
Accuracy of O3 Sensor by ARMS Calculation of Percent rSO2
Accuracy of the sensors will be determined by comparing somatic regional oxygen saturation (rSO2) readings from the O3 sensor and blood reference oxygen saturation values and calculating the Arithmetic root mean square (ARMS).
Time frame: 1 visit up to 8 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Healthy Adult Volunteers | Accuracy of O3 Sensor by ARMS Calculation of Percent rSO2 | 4.78 percentage of regional oxygen saturation |