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This study will evaluate the efficiency of the EcoAnesthesia mask and its advantages over the standard facemask used in our practice. The satisfaction by the anesthesia provider and its ease of use may change the standard practice in airway management. In addition to these additional effects on patient safety, the facemask is affordable and may reduce the environmental burden of anesthesia waste.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EcoAnesthesia Mask first | Active Comparator | Both the "standard adult facemask" (Portex Adult, USA) and the new facemask (EcoAnesthesia Mask, Intersurgical, Inc., Liverpool, NY, USA) will be tested in each patient for three minutes. The order of usage of each mask will be randomly assigned to each patient. This group will receive the EcoAnesthesia Mask first. |
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| Standard mask first | Active Comparator | Both the "standard adult facemask" (Portex Adult, USA) and the new facemask (EcoAnesthesia Mask, Intersurgical, Inc., Liverpool, NY, USA) will be tested in each patient for three minutes. The order of usage of each mask will be randomly assigned to each patient. Patients in this arm will receive the standard mask first. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EcoAnaesthesia facemask first | Device | The trial facemask will be used before the standard one. |
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| Measure | Description | Time Frame |
|---|---|---|
| End-tidal oxygen concentration | End-tidal oxygen concentration after 3 minutes with the mask that the patient was first randomized to use. | three minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum airway pressure | Maximum airway pressure, which will be necessary to reach a tidal volume of at least 6 ml/kg every minute during the 3 minutes of mask ventilation with each device. | End of 3 minutes with each mask |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Detlef Obal, MD | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville Hospital | Louisville | Kentucky | 40202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19293691 | Background | Kheterpal S, Martin L, Shanks AM, Tremper KK. Prediction and outcomes of impossible mask ventilation: a review of 50,000 anesthetics. Anesthesiology. 2009 Apr;110(4):891-7. doi: 10.1097/ALN.0b013e31819b5b87. |
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| Portex Adult (Standard) facemask first | Device | The standard facemask will be applied before the trial device. |
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| Portex Adult (Standard) facemask second | Device | The standard facemask will be applied after the trial device |
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| EcoAnesthesia facemask second | Device | The trial facemask will be used after the standard one. |
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