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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: Completed study, sponsored by United States Naval Medical Center, San Diego.

NCT02403934 is a clinical trial that has completed, run by United States Naval Medical Center, San Diego. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 50 participants
Start Date 2014-10
Est. Completion 2015-04

What the finished NCT02403934 record still lists

NCT02403934 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Jaw Elevation Device (JED) is the first listed.

NCT02403934 does not publish any study locations in the registry export this page uses.

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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Source: ClinicalTrials.gov NCT02403934, the US trial registry maintained by the National Library of Medicine. NCT02403934 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.