EcoAnaesthesia Facemask Versus Standard Facemask During Anesthesia Induction
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|ClinicalTrials.gov Identifier: NCT01103947|
Recruitment Status : Withdrawn (Not able to finalize funding)
First Posted : April 15, 2010
Last Update Posted : April 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia Induction||Device: EcoAnaesthesia facemask first Device: Portex Adult (Standard) facemask first Device: Portex Adult (Standard) facemask second Device: EcoAnesthesia facemask second||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||A Comparison of the Efficiency of the New EcoAnaesthesia Facemask With a Standard Facemask During Induction of Anesthesia|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2014|
Active Comparator: EcoAnesthesia Mask first
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
The trial facemask will be used before the standard one.Device: Portex Adult (Standard) facemask second
The standard facemask will be applied after the trial device
Active Comparator: Standard mask first
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
The standard facemask will be applied before the trial device.Device: EcoAnesthesia facemask second
The trial facemask will be used after the standard one.
- End-tidal oxygen concentration [ Time Frame: three minutes ]End-tidal oxygen concentration after 3 minutes with the mask that the patient was first randomized to use.
- Maximum airway pressure [ Time Frame: End of 3 minutes with each mask ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01103947
|United States, Kentucky|
|University of Louisville Hospital|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Detlef Obal, MD||University of Louisville|