Hypoxia, Obesity, OSA
Conditions
Keywords
hypoxia, hypoxic, desaturation, deoxygenation, obstructive sleep apnea, obesity, mask ventilation, oral pharyngeal airway, distal pharyngeal airway, induction, difficult airway
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDPA
Anesthesiologist will use novel DPA device post anesthetic induction to assist in bag mask ventilation prior to endotracheal tube placement.
DEVICEOPA
Anesthesiologist will use standard OPA device post anesthetic induction to assist in bag mask ventilation prior to endotracheal tube placement.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Comparison of two groups: 1) Oral pharyngeal airway (OPA) group 2) Distal pharyngeal airway (DPA) group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient presenting for surgery at main Stanford Hospital * Over 18 years old * ASA Class II, III, IV * High risk for hypoxic events during intubation based on their past medical history * BMI \>35 * Likelihood of obstructive sleep apnea utilizing the STOP-BANG questionnaire * History of diagnosed sleep apnea * History of difficult intubation * Prior need for two-handed mask ventilation * Requiring general anesthesia with endotracheal intubation for surgery
Exclusion criteria
* Altered mental status * Anesthesia technique includes rapid sequence or modified rapid sequence intubation * Poorly controlled gastroesophageal reflux
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with clinically significant hypoxia SpO2 < 92 | Post-treatment recorded intra-operatively (up to 24 hours) | This outcome will be compared between two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of obstruction for sedated patients arriving in postoperative care with an airway in situ | Immediately post-operatively (up to 24 hours) | 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. |
| Number of additional airway maneuvers used during bag-mask ventilation with the MEA DPA and OPA during induction of general anesthesia | 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 | Post-treatment recorded intra-operatively (up to 24 hours) | 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. |
| Change in anesthesia provider satisfaction during anesthetic bag-mask ventilation (positive pressure ventilation) | Immediately post-operatively (up to 24 hours) | 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. |
Outcome results
None listed