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| Name | Class |
|---|---|
| University Medical Center Groningen | OTHER |
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Testing the absolute accuracy of the Masimo O3 regional oximeter in reading somatic tissue oxygenation in healthy volunteers under controlled hypoxia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Adult Volunteers | Experimental | Controlled hypoxia will be induced and Masimo O3 regional oximeter-derived tissue oxygen saturation (rSO2) readings of somatic tissue will be measured. The readings will be compared with blood reference oxygen saturation values. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Masimo O3 Regional Oximeter | Device | Study sensors will be placed on somatic tissues. Readings will be taken from the tissues underneath the O3 sensors. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1 visit up to 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 1 | Groningen | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36463540 | Derived | De Keijzer IN, Massari D, Niezen CK, Bokkers RPH, Vos JJ, Scheeren TWL. Agreement of somatic and renal near-infrared spectroscopy with reference blood samples during a controlled hypoxia sequence: a healthy volunteer study. J Clin Monit Comput. 2023 Jun;37(3):805-814. doi: 10.1007/s10877-022-00944-9. Epub 2022 Dec 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Number | percentage of regional oxygen saturation | 1 visit up to 8 hours |
|
1 visit up to 8 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe vasovagal reaction | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cristina Johnson | Masimo Corporation | (949) 297-7576 | clinicalresearchdept@masimo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 17, 2021 | May 31, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 37 |
| 1 |
| 37 |
| 17 |
| 37 |
| Hematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Lightheadedness | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Drop in blood pressure | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Elevated heart rate | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Unusual sensation near right kidney | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Pressure near arterial line site | Injury, poisoning and procedural complications | Non-systematic Assessment |
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