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NCT02403934 · ClinicalTrials.gov registry record
Jaw Elevation Device in Deep Sedation Study
A clinical trial, sponsored by United States Naval Medical Center, San Diego.
- Completed
- Registry status
- 50
- Enrollment target
NCT02403934 is a clinical trial that has completed, run by United States Naval Medical Center, San Diego. The registered enrollment target is 50 participants.
The verdict
NCT02403934 has completed, sponsored by United States Naval Medical Center, San Diego.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
Study 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 deep sedati
Interventions
- DEVICE Jaw Elevation Device (JED)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2014-10 |
| Est. Completion | 2015-04 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02403934
The ClinicalTrials.gov registry entry for NCT02403934 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United States Naval Medical Center, San Diego, which has 41 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Jaw Elevation Device (JED) is the first listed.
NCT02403934 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02403934 about?
NCT02403934 is a clinical study titled "Jaw Elevation Device in Deep Sedation Study". 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 ...
What is the current status of trial NCT02403934?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2014-10. Estimated completion is 2015-04.
What interventions are being tested in trial NCT02403934?
The interventions under investigation include: Jaw Elevation Device (JED) (DEVICE).
Who is sponsoring clinical trial NCT02403934?
This trial is sponsored by United States Naval Medical Center, San Diego, which has 41 total clinical trials registered on ClinicalTrials.gov.
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