Cohort 2 Efficacy of Nasopharyngeal Ventilation With Endotracheal Tube for Surgery (MASK)
Failed mask ventilation poses an increased risk of de-oxygenation to the patient undergoing general anesthesia. Nasopharyngeal ventilation may be a valid alternative for mask ventilation allowing for better oxygenation during the induction phase of general anesthesia. Oxygenation may be maintained better in case of difficult mask ventilation. This study evaluates this alternative method in comparison with the standard method of mask ventilation.
General Design This is a randomized, controlled, cross over study. Patients will be randomized to mask ventilation followed by nasopharyngeal airway placement and ventilation or vice versa.
Primary Study Endpoints We will test the hypothesis that ventilation via a nasally placed ETT is superior in its efficacy (as measured by tidal volume) to routine facemask ventilation in patients undergoing general anesthesia and endotracheal intubation for their surgery.
|General Anesthesia With Endotracheal Intubation in Surgery||Other: Mask then nasopharyngeal Other: Nasopharyngeal then mask|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Prevention
|Official Title:||Cohort 2 Efficacy of Nasopharyngeal Ventilation With Endotracheal Tube for Patients With Predicted Difficult to Mask Ventilate|
- Tidal volume [ Time Frame: 15 minutes ]After facemask or nasopharyngeal ventilation
- Airway pressure [ Time Frame: 3 min after facemask or nasopharyngeal ventilation ]
|Study Start Date:||June 2015|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||November 2017 (Final data collection date for primary outcome measure)|
Nasopharyngeal then mask
Patients will be randomized to nasopharyngeal airway placement and ventilation followed by mask ventilation
Other: Nasopharyngeal then mask
Patients will be randomly assigned to naso-pharyngeal ventilation followed by mask ventilation.
Mask then nasopharyngeal
Patients will be randomized to mask ventilation followed by nasopharyngeal airway placement and ventilation
Other: Mask then nasopharyngeal
Patients will be randomly assigned to Mask ventilation followed by naso-pharyngeal ventilation
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02018146
|Contact: Rainer Lenhardt, MDemail@example.com|
|United States, Kentucky|
|University of Louisville||Recruiting|
|Louisville, Kentucky, United States, 40202|
|Contact: Elizabeth Cooke, RN 502-852-5851 firstname.lastname@example.org|
|Principal Investigator: Rainer Lenhardt, M.D.|
|Principal Investigator:||Rainer Lenhardt, MD||University of Louisville School of Medicine|