The goal of the study is to compare deoxygenation events during anesthesia induction and mask ventilation when using standard oral pharyngeal airways or the novel distal pharyngeal airway.
This prospective RCT will study adult patients who are determined to be at high risk for deoxygenation events during induction of general anesthesia. The study will randomize patients for use of a novel airway device (distal pharyngeal airway) versus standard oral pharyngeal airway during general anesthetic induction and measure differences in severity and duration of desaturation (hypoxic) events. The premise is the new novel device will reduce hypoxic events, improving patient safety and reducing airway complications. This is critically important as hypoxic events can have significant consequences. Providing a device that minimizes hypoxic events could impact patient safety positively. Additional measurements will include reduction in unanticipated patient admissions from airway complications with DPA use.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Anesthesiologist will use novel DPA device post anesthetic induction to assist in bag mask ventilation prior to endotracheal tube placement.
Anesthesiologist will use standard OPA device post anesthetic induction to assist in bag mask ventilation prior to endotracheal tube placement.
Number of participants with clinically significant hypoxia SpO2 < 92
This outcome will be compared between two groups.
Time frame: Post-treatment recorded intra-operatively (up to 24 hours)
Number of additional airway maneuvers used during bag-mask ventilation with the MEA DPA and OPA during induction of general anesthesia
Time frame: Post-treatment recorded intra-operatively (up to 24 hours)
Determine if additional airway maneuvers are used during bag-mask ventilation with the MEA DPA and OPA during induction of general anesthesia
The number of supplemental airway interventions that the anesthesiologist must use to be able to ventilate the patient after the OPA or MEA DPA placement will be assessed. These supplemental interventions include chin lifts, jaw thrusts, head repositioning, and asking for additional aid when ventilating the patient. These notes will be compared and confirmed with the recorded induction footage from the cameras. Following data collection, data will be compared to demonstrate if there is a reduction in the need for manual intervention with the MEA DPA compared to a standard airway.
Time frame: Post-treatment recorded intra-operatively (up to 24 hours)
Change in anesthesia provider satisfaction during anesthetic bag-mask ventilation (positive pressure ventilation)
Anesthesiologists will be asked if the MEA DPA is easier, harder, or has the same level of difficulty in placement and use as the standard OPA. Following data collection, the differences between the intervention and control group will be compared to demonstrate improved anesthesia provider satisfaction based on ease of placement, use and preferred future usage of MEA DPA.
Time frame: Immediately post-operatively (up to 24 hours)
Incidence of obstruction for sedated patients arriving in postoperative care with an airway in situ
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PACU nurse will indicate if the MEA DPA correlates with reduced post-operative care unit (PACU) airway manipulation (head repositioning, jaw thrust, increased oxygen flows). Following data collection, the differences between the intervention and control group will be compared to demonstrate preferred use through decreased airway management needs for PACU nurses with the DPA and reduced patient discomfort.
Time frame: Immediately post-operatively (up to 24 hours)