Cohort 2 Efficacy of Nasopharyngeal Ventilation With Endotracheal Tube for Surgery

Completed · Not applicable

Conditions studied: General Anesthesia With Endotracheal Intubation in Surgery

In brief

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.

Key facts

Study ID

NCT02018146

Run by

University of Louisville

People needed

41

Starts

2015-06-01

Expected to finish

2018-05-01

Last updated by the study team

2019-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects undergoing general anesthesia and require endotracheal intubation.
• Adults patients 18 years or greater
• Subjects are capable of understanding and signing the Informed Consent Form or have an acceptable representative capable of giving legally authorized consent on their behalf.
• Meet three or more of predictive difficult to mask criteria as listed:
• Age = or > than 55
• BMI = or > than 30
• Edentulism
• History of snoring and/or a diagnoses of obstructive sleep apnea
• STOP/BANG score of three or greater
• Presesnce or a beard or mustach that covers the part of the face in conntact with the facemask edges
• Male gender
• History of neck radiation
• Mallampati score of III or IV

You may not qualify if…

• Subjects will be excluded from this study in cases where there will not be an attempt at mask ventilation. This includes patients that will require an awake fiberoptic intubation as well as those needing a rapid sequence intubation.
• Subjects with full stomachs, known hiatal hernia, and severe gastroesophageal reflux will be excluded.
• Subjects with known or suspected basilar skull fractures will be excluded.

Where it is running

• University of Louisville — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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