Jaw Elevation Device in Deep Sedation Study

Completed

Conditions studied: Airway Obstruction

In brief

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 deep sedation or MAC. A jaw thrust maneuver will be initially performed to demonstrate that each patient's airway can be adequately supported by this maneuver. The JED will then be placed in order to maintain a patent airway, while leaving the level of sedation unchanged. Intraoperative monitoring, continuous ECG, pulse oximetry, blood pressure, capnography, will be routine, and determined by the anesthesia team. The investigators will also track how often the provider was required to adjust the JED to maintain a patent airway, and if the need to convert to an alternate method of airway management was required. The investigators will pursue publication of the results as the first study demonstrating the efficacy of the JED.

Key facts

Study ID

NCT02403934

Run by

United States Naval Medical Center, San Diego

People needed

50

Starts

2014-10-01

Expected to finish

2015-04-01

Last updated by the study team

2016-08-22

Who can join

Age: 18 and older, up to 48. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Adult female patients undergoing egg retrieval for infertility requiring deep sedation or MAC and
• who can lie in the supine position throughout the entire procedure.

You may not qualify if…

• Adult female patients who are known to have allergies or intolerances to the intended sedative medications that will be used as the primary anesthetic and
• patients who have an upper airway, facial, or jaw anatomic abnormality that the anesthesia provider determines would be inappropriate to use the JED.

Where it is running

• NMCSD — San Diego, California, United States

Full record on ClinicalTrials.gov

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