Oxygen Deficiency
Conditions
Brief summary
This is a validation study of a near-infrared spectroscopy (NIRS) device designed to measure the cerebral tissue oxygen saturation.
Interventions
DEVICEDesaturation
The delivered gas mixture will be adjusted to decrease the displayed saturation of peripheral oxygen. Each desaturation steps are of approximately 5 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%.
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 46 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy, male or female subjects between the ages of 18 to ≤46 years; 2. Completion of a health screening for a medical history by a licensed physician, nurse practitioner or physician assistant; 3. Minimum weight 40kg; 4. BMI within range 18.0 - 30.0.
Exclusion criteria
1. Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain) \[self-reported\]; 2. Prior known severe allergies to medical grade adhesive/tape (Band-Aid) \[self-reported\]; 3. Taking any medication other than birth control \[self-reported\]; 4. Is currently participating in, or has recently participated in (discontinued within 30 days prior to the hypoxia procedure for this study) in an investigational drug, device, or biologic study \[self-reported\]; 5. Has a negative Allen's Test to confirm non-patency of the collateral artery \[clinical assessment by PI or delegate\]; 6. Has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure \[self-reported\]; 7. Is female with a positive pregnancy test \[serum or urine\], or is female and is unwilling to use effective birth control between the time of screening and study procedure or is breastfeeding; 8. Has anemia \[lab values specific for gender\]; 9. Has a history of sickle cell trait or thalassemia \[self-reported\]; 10. Has an abnormal hemoglobin electrophoresis test \[lab measurement\]; 11. Has a positive urine cotinine test or urine drug screen or oral ethanol test \[POC testing\]; 12. Has a room air saturation less than 95% by pulse oximetry \[measurement by PI or delegate\]; 13. Has a clinically significant abnormal ECG \[assessment by PI or delegate\]; 14. Has a clinically significant abnormal pulmonary function test via spirometry \[assessment by PI or delegate\]; 15. Has a COHb greater than 3%, or MetHb greater than 2% \[measured by venous blood sample co-oximetry\]
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validated the Next Generation Oximeter | Data collected from individual participant over 4 hour timeframe. | Cerebral overall mean bias (percentage saturation) defined as the average of the differences between the regional saturation (rSO2) value and (fSO2) value obtained from simultaneous arterial and jugular venous blood samples. Cerebral trending is defined as the measurement of changes in regional saturation (rSO2) under conditions of changing fSO2. Cerebral trending mean bias is the average difference between changes in rSO2 values compared against changes in fSO2. Somatic trending mean bias is defined the same as Cerebral trending mean bias except for the location of measurement on the subjects and for Somatic trending mean bias, rS02 was compared to rSO2 on a commercially-available regional oximetry monitor. The smaller value the better performance. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Desaturation Volunteers undergo oxygen desaturation in order to determine the accuracy of the device over a clinical range of oxygen saturations 70 - 100%.
Desaturation: The delivered gas mixture will be adjusted to decrease the displayed saturation of peripheral oxygen. Each desaturation steps are of approximately 5 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%. | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | Desaturation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants |
| Age, Continuous | 31.4 years STANDARD_DEVIATION 6.66 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 32 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 2 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
Primary
Validated the Next Generation Oximeter
Cerebral overall mean bias (percentage saturation) defined as the average of the differences between the regional saturation (rSO2) value and (fSO2) value obtained from simultaneous arterial and jugular venous blood samples. Cerebral trending is defined as the measurement of changes in regional saturation (rSO2) under conditions of changing fSO2. Cerebral trending mean bias is the average difference between changes in rSO2 values compared against changes in fSO2. Somatic trending mean bias is defined the same as Cerebral trending mean bias except for the location of measurement on the subjects and for Somatic trending mean bias, rS02 was compared to rSO2 on a commercially-available regional oximetry monitor. The smaller value the better performance.
Time frame: Data collected from individual participant over 4 hour timeframe.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Desaturation | Validated the Next Generation Oximeter | Cerebral Overall Mean Bias | 1.22 Percentage saturation | Standard Deviation 5.92 |
| Desaturation | Validated the Next Generation Oximeter | Cerebral Overall Trending Mean Bias | 0.83 Percentage saturation | Standard Deviation 3.08 |
| Desaturation | Validated the Next Generation Oximeter | Somatic Overall Trending Mean Bias | 0.09 Percentage saturation | Standard Deviation 1.73 |