An interventional study of EcoAnaesthesia facemask first and Portex Adult (Standard) facemask first in Anesthesia Induction, sponsored by University of Louisville. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-04-07.
Sponsored by University of Louisville · Not applicable, Interventional, and Health services research
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.
University of Louisville is the lead sponsor of 284 studies on the registry; 53 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 7 (35%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: EcoAnaesthesia facemask first · Device: Portex Adult (Standard) facemask second
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.
Device: Portex Adult (Standard) facemask first · Device: EcoAnesthesia facemask second
The trial facemask will be used before the standard one.
The standard facemask will be applied before the trial device.
The standard facemask will be applied after the trial device
The trial facemask will be used after the standard one.
End-tidal oxygen concentration
End-tidal oxygen concentration after 3 minutes with the mask that the patient was first randomized to use.
Time frame: three minutes
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.
Time frame: End of 3 minutes with each mask
This study is withdrawn, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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University of Louisville