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The purpose of this study is to evaluate the safety of using the AnapnoGuard 100 system during the course of mechanical ventilation and intubation of critical care patients in Intensive Care Unit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Patients intubated with AnapnoGuard EndoTracheal Tube and connected to the AnapnoGuard 100 Control System |
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| Control Group | No Intervention | Patients intubated with the Standard of Care EndoTracheal Tube and Connected to a Suction Regulator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AnapnoGuard 100 System | Device | AnapnoGuardâ„¢ 100 Respiratory Guard System is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube's cuff. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of AE (adverse events) and SAE (serious adverse events) | participants will be followed for the entire duration of intubation (an expected average of 8 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Massimo Antonelli, Prof. | Director of General ICU and Institute of Anesthesiology and Intensive Care, Policlinico Universitario A. Gemelli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico Universitario A. Gemelli | Rome | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28493877 | Derived | De Pascale G, Pennisi MA, Vallecoccia MS, Bello G, Maviglia R, Montini L, Di Gravio V, Cutuli SL, Conti G, Antonelli M. CO2 driven endotracheal tube cuff control in critically ill patients: A randomized controlled study. PLoS One. 2017 May 11;12(5):e0175476. doi: 10.1371/journal.pone.0175476. eCollection 2017. |
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