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Single-arm, feasibility study to evaluate the Ceragenin Coated Endotracheal Tube (the CeraShield ETT) in adults who require intubation and are expected to be mechanically ventilated for ≥ 24 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CeraShield Endotracheal Tube | Experimental | Subjects who are expected to require mechanical ventilation for 24 hours or longer will be intubated with the CeraShield ETT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CeraShield Endotracheal Tube | Device | Subjects requiring mechanical ventilation with be intubated with the CeraShield ETT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | The safety of the CeraShield ETT tube will be assessed by reviewing adverse events in all patients enrolled in the study | Up to 30 days post enrollment or hospital discharge, whichever comes first |
| Measure | Description | Time Frame |
|---|---|---|
| Positive QEA | Determine the incidence of subjects with positive QEA in the patients intubated ≥ 24 hours | 10 days post intubation |
| Positive ETT colonization | Determine the incidence of subjects with ETT colonization in the patients intubated ≥ 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jane Wilson | Contact | 845-721-8210 | janew@databean.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kingston Health Sciences Centre | Recruiting | Kingston | Ontario | K7L 2V7 | Canada |
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| 10 days post intubation |