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The decision was made to withdraw this study prior to recruitment to make further changes to the investigational device.
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| Name | Class |
|---|---|
| Duke University Hospital, USA | UNKNOWN |
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The purpose of this study is to calibrate and validate a cerebral oximeter product from Cyban Pty. Ltd. The study will involve comparing cerebral oximeter signals against reference arterial and jugular bulb blood gas measures.
The primary objective of the study is to measure the absolute and relative accuracy of the StO2 device by comparing the NIRS-derived brain tissue oxygen saturation with blood-referenced CO-oximeter oxygen saturation values. The CO-oximeter oxygen saturation values from paired arterial and jugular bulb blood samples are combined into a weighted-equation to derive the reference SavO2. Accuracy is reported over a range of oxygen saturations with study subjects exposed to a controlled oxygen desaturation with serial sampling of paired arterial and internal jugular venous blood gas samples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desaturation | Experimental | A central venous catheter will be placed in the right internal jugular vein and the catheter tip advanced retrograde to lie at the level of the jugular bulb. An arterial catheter will be placed in the forearm. A dedicated breathing circuit will be used to reduce the alveolar oxygen tension (PAO2) in stepwise fashion to produce a controlled oxygen desaturation sequence. The dedicated breathing circuit will be used to maintain the alveolar carbon dioxide tension (PACO2) at normocapnic value of 40 mmHg. At each step once steady state conditions are achieved, serial paired arterial and jugular bulb venous samples will be drawn. The blood gas samples will be analyzed by Radiometer ABL90 Flex CO-oximeter. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypoxia in healthy individuals | Procedure | The subject will undergo a graduated desaturation procedure. Arterial saturation targets are as follows:
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| Measure | Description | Time Frame |
|---|---|---|
| Accuracy by Average Root Mean Squared Error | The Accuracy by Root Mean Square Difference (ARMS) will be used to evaluate accuracy of the investigational device StO2 compared with the blood-referenced SavO2 | 6 months |
| Bland-Altman Agreement Analysis | A Bland-Altman (BA) analysis will be conducted on the difference (D) and mean (A) of StO2, SavO2, where
The following statistics will be presented:
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Concordance Correlation Coefficient | The concordance correlation coefficient (CCC) method is used to measure the agreement between of two devices. CCC could have values from -1 to 1, with values near 1 indicating strong concordance between the two devices, values near -1 indicating strong discordance, and values near zero indicating no concordance. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Analyses | All safety analyses will be conducted on the Safety Population. No inferential statistical testing will be performed for safety variables. Any reported adverse events, safety observations, and adverse device deficiencies will be listed in a separate by participant data listing. | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David B Macleod, M.B.B.S | Human Pharmacology and Physiology Lab, Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina, USA | Principal Investigator |
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There is no plan to share individual participant data.
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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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Subject will undergo a graduated desaturation protocol beginning at 100%, then 99%, then descending in 3% increments to a final target of 66%. Arterial and venous jugular bulb co-oximetry measurements will be taken at each saturation plateau yielding a total of 13 paired samples per subject. The weighted average of the SaO2 and the SvO2 will be compared against the Cyban Cerebral Oximeter.
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| Cerebral Oximetry | Device | Each subject will be continuously monitored with the cerebral oximetry device throughout the desaturation procedure. |
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| Blood Gas Sampling | Diagnostic Test | At each arterial saturation plateau venous and arterial blood gas measurements will be taken from the jugular bulb, and the radial artery respectively. |
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| Passing-Bablok Regression Analysis | Passing-Bablok regression is used to compare measurements from different devices, and is a robust nonparametric regression method that does not make assumptions about the distribution of the expected values or the error terms in the model. The 95% CI for the intercept and slope will be estimated from the regression. | 6 months |
| Linear Mixed Model Regression Analysis | A random effects linear mixed model will be used to regress StO2 on SavO2. Subject will be included as a random effect in the model to account for the correlation of repeated measures within the same subject. | 6 months |
| Subgroup Analysis of Agreement | Bland-Altman analyses will be generated for subgroups to assess the two device agreement among different subgroups. A forest plot will used to present the results. The following subgroups will be considered.
| 6 months |