Clinical Trial: Jaw Elevation Device in Deep Sedation Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: The Use of Jaw Elevation Device in Deep Sedation

Brief Summary: Maintaining a patent airway is a constant concern to any anesthesia provider performing deep sedation cases. The doses of sedative medications often required for the desired level of sedation in a patient often result in occlusion of the airway and the patient becoming apneic. Opening the collapsed or occluded airway requires the use of an invasive airway device, (e.g. laryngeal mask airway (LMA), oral airway or nasal airway) or the application of a jaw thrust maneuver. When the provider provides jaw thrust while attending to the other duties, the patient may not have adequate ventilation and the patient's oxygen saturation can fall producing hypoxemia. Airway management devices currently available require deeper levels of sedation to be tolerated by patients. In order to avoid the need for internal airway devices, providers attempt to carefully adjust the level of sedation so that no airway support is required. For safety, providers usually try to stay on the "light" side of the sedation scale. Unfortunately, this often results in an uncomfortable patient or one who is moving too much to successfully carry out the procedure. Until the availability of the Jaw Elevation Device (JED) there was no external device providers could utilize to assist in opening a patient's airway. By duplicating the jaw thrust maneuver, the JED maintains a patent airway. Once applied, it frees the anesthesia provider to attend to other duties associated with administration of anesthesia without requiring the provider to manually maintain a jaw thrust maneuver. The advantages with such a device would allow a level of sedation deep enough for the patient to tolerate the procedure as well as maintain a patent airway. To date, there have not been any studies evaluating the JED in clinical practice. The investigators wish to evaluate the JED in a standardized fashion during deep sedation or monitored anesthesia care (MAC). Our study would involve 50 patients who became apneic during d

Detailed Summary:

1. General Approach: 50 Research subjects will be selected from patients scheduled to undergo transvaginal oocyte (egg) retrieval under sedation or MAC. Sedation for these procedures typically consists of intravenous administration of a combination of midazolam, fentanyl, propofol, and/or ketamine titrated until the patient is calm, while supplemental oxygen is provided by mask or nasal cannula. A continuous infusion of propofol is then begun to keep the patient sedated enough that they will lie still and breathe regularly, but still respond to commands or noxious stimuli (such as a sternal rub). As per standard anesthetic care, each patient will have their oxygen saturation, end-tidal carbon dioxide waveform and heart rate/rhythm measured continuously while the anesthesia care provider monitors the patient for signs of inadequate respiration and airway obstruction. These signs include a loss of the end-tidal carbon dioxide waveform, snoring, paradoxical ventilation, cessation of ventilatory efforts, or a reduction in the oxygen saturation. Typically, whenever these signs are present, the anesthesia provider provides a jaw thrust to open the patient's airway and restore adequate ventilation. Once accomplished, the anesthesia care provider typically lowers the dose of anesthetic and releases jaw thrust. If signs of airway obstruction recur, jaw thrust is applied again until the level of sedation has reached a level low enough that the patient can breathe without airway support. However, this may lead to inadequate sedation, patient movement and difficulty for the surgeon to perform the procedure. The depth of sedation required for the egg retrieval procedure frequently results in needing to perform a jaw thrust or placing an airway device to maintain airway patency. Applying the JED after a jaw thrust may alleviate the airway obstruction while allowing adequate sedation to be maintained without a compromise in the anesthe
Sponsor: United States Naval Medical Center, San Diego

Current Primary Outcome: To evaluate the efficacy of a new external airway support device, the JED, when used during deep sedation or MAC in women undergoing egg retrieval. # of air way obstructions (Measured Sa02<90%) [ Time Frame: Number of Minutes from start of procedure to end of procedure up to 100 minutes ]

Original Primary Outcome: To evaluate the efficacy of a new external airway support device, the JED, when used during deep sedation or MAC in women undergoing egg retrieval. # of air way obstructions (Measured Sa02<90%) [ Time Frame: from start of procedure to end of procedure ]

Current Secondary Outcome: Change from deep anesthesia to general anesthesia [ Time Frame: Number of minutes from start of procedure to end of procedure up to 100 minutes ]

Original Secondary Outcome: Change from deep anesthesia to general anesthesia [ Time Frame: from start of procedure to end of procedure ]

Information By: United States Naval Medical Center, San Diego

Dates:
Date Received: February 19, 2015
Date Started: October 2014
Date Completion:
Last Updated: August 18, 2016
Last Verified: August 2016