Cohort 2 Efficacy of Nasopharyngeal Ventilation With Endotracheal Tube for Surgery (MASK)
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|ClinicalTrials.gov Identifier: NCT02018146|
Recruitment Status : Active, not recruiting
First Posted : December 23, 2013
Last Update Posted : February 15, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|General Anesthesia With Endotracheal Intubation in Surgery||Other: Mask then nasopharyngeal Other: Nasopharyngeal then mask||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cohort 2 Efficacy of Nasopharyngeal Ventilation With Endotracheal Tube for Patients With Predicted Difficult to Mask Ventilate|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
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
- Tidal volume [ Time Frame: 15 minutes ]After facemask or nasopharyngeal ventilation
- Airway pressure [ Time Frame: 3 min after facemask or nasopharyngeal ventilation ]
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): NCT02018146
|United States, Kentucky|
|University of Louisville|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Rainer Lenhardt, MD||University of Louisville School of Medicine|