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The purpose of the study is to validate the diagnostic performance of the amplified pretracheal stethoscope (APS) to detect sedation-related adverse acute respiratory events in propofol sedated nonintubated children. To determine the sensitivity/specificity and positive/negative predictive value of the APS in detecting sedation-related adverse acute respiratory events in propofol sedated nonintubated children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APS | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| An auscultation of a stridor score greater than or equal to 2 will be defined as a sedation-related adverse acute respiratory event | Day 1 of propofol sedation. | |
| A stridor score of less than 2 will be defined as not sedation-related event. | Day 1 of sedation. |
| Measure | Description | Time Frame |
|---|---|---|
| The positive predictive value and negative predictive value of the APS for predicting airway obstruction. | A subject will be considered as evaluable for the sensitivity/specificity evaluation if (1) all inclusion criteria are met, (2) presedation phase is completed, and (3) the sedation induction and maintenance phase is completed. | Day 1 of propofol sedation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Boriosi, MD | UW Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Family Children's Hospital (AFCH) | Madison | Wisconsin | 53792 | United States |
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