Surgery
Conditions
Brief summary
The study will collect cerebral oximetry data from pediatric and neonatal subjects using the Masimo O3 regional oximetry device, for the purposes of device calibration and validation.
Interventions
DEVICEO3 regional oximeter sensor
Noninvasive sensor that is placed on the forehead for measurement of oxygenation in the area under the sensor
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric patients undergoing cardiac catheterization procedure for treatment or diagnosis of cardiovascular disease * 1 day to less than 18 years of age * Weight between 3.5 and 40 kg * Parental or legal guardian consent and subject assent
Exclusion criteria
* Failure to obtain written consent * Equal or more than 18 years in age * Weight more than 40kg or less than 3.5kg * Jaundice with bilirubin levels higher than the reference range * 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 motioning of SpO2 levels during the study or placement of cerebral oximeter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Sensor by Arms Calculation of Percent rSO2 | One visit; up to 4 hours | The continuous measurements of regional oxygen saturation (rSO2) was compared against its reference cerebral oxygen saturation which is measured by a combination of arterial and jugular venous blood oxygen saturation. Absolute accuracy was determined by the root-mean-squared error (Arms). The Arms error value is calculated as the square root of the sum of the squares of mean bias and estimated standard deviation of bias. The bias is defined as the difference of the rSO2 and its blood reference. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| O3 Regional Oximeter Sensors All subjects are enrolled in the test group and receive the O3 regional oximeter sensor during their scheduled, general cardiac catheterization procedure.
O3 regional oximeter sensor: Noninvasive sensors are placed on the forehead for measurement of oxygenation in the area under the sensor. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 6 |
Baseline characteristics
| Characteristic | O3 Regional Oximeter Sensors |
|---|---|
| Age, Customized 0-23 months | 14 Participants |
| Age, Customized 2-12 years | 19 Participants |
| Race/Ethnicity, Customized Ethnicity Asian | 4 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic/Latino | 11 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic | 2 Participants |
| Race/Ethnicity, Customized Ethnicity White | 16 Participants |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 44 |
| other Total, other adverse events | 2 / 44 |
| serious Total, serious adverse events | 0 / 44 |
Outcome results
Primary
Accuracy of Sensor by Arms Calculation of Percent rSO2
The continuous measurements of regional oxygen saturation (rSO2) was compared against its reference cerebral oxygen saturation which is measured by a combination of arterial and jugular venous blood oxygen saturation. Absolute accuracy was determined by the root-mean-squared error (Arms). The Arms error value is calculated as the square root of the sum of the squares of mean bias and estimated standard deviation of bias. The bias is defined as the difference of the rSO2 and its blood reference.
Time frame: One visit; up to 4 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| O3 Regional Oximeter Sensors (Test Group) | Accuracy of Sensor by Arms Calculation of Percent rSO2 | 5.0 %rSO2 |