Jaw Elevation Device in Deep Sedation Study
Condition: Airway Obstruction
MeSH terms: Airway Obstruction
Study type: Observational

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 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.
    

Detailed description: 
      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 anesthetic depth.

      2. Description: Prior to anesthesia, all subjects will be given supplemental oxygen and
      monitored with pulse oximetry, end tidal carbon dioxide (ETCO2) capnography, noninvasive
      blood pressure, heart rate and rhythm measurement. In this study, once the patient is sedated
      and inadequate ventilation is identified as stated above, a jaw thrust maneuver will be
      applied. If this maintains adequate ventilation the JED will then be placed on the patient
      and adjusted to produce a simulated jaw thrust in an effort to open the obstructive airway.
      Once the JED is appropriately placed and clinical signs of ventilation achieved, the
      investigator will document the number of times that the anesthesia provider must manipulate
      the JED device to achieve an adequate airway. If at any time the anesthesia care provider
      feels that the JED cannot be adjusted to successfully maintain the airway, the use of the JED
      will be discontinued and the anesthesia provider will employ an airway management technique
      of their choice. In addition, the time of initial placement of the JED until end of JED use
      will be recorded to obtain total time of JED use during the anesthetic. The number of
      adjustments per unit time of JED use will then be calculated to compare to a constant jaw
      thrust that would otherwise be required. The duration of anesthesia administration with also
      be collected beginning with induction of anesthesia/sedation until cessation of infusion. The
      study will be continued until 50 patients have been entered into the study. Information will
      be collected even if the patient does not require a jaw thrust and the JED is not placed. Due
      to the high frequency of requiring airway assistance with egg retrieval procedures performed
      under deep sedation, the incidence of patients not requiring assistance is likely to be low
      and 50 patients was felt to be an adequate study size to describe the utility and efficacy of
      the JED in this setting.

      3 Methods: One of the above listed investigators will observe the anesthetic and collect
      observed data listed on the attached data collection sheet. Data to be collected will include
      the following:

      Data point Method of measurement Date of procedure day/month/year (DD/MM/YYYY) Patient gender
      Population is all female ASA class 1-6 Age In years Height inches Weight kilograms BMI Kg/m2
      Patient ethnicity How patient identifies Patient history of obstructive sleep apne (OSA)
      Asked pre-operatively STOP-BANG score Asked pre-operatively Patient diagnosis Infertility
      Duration of anesthetic medication administration Minutes:seconds Medication used Name of
      medication Medication dose Mg, mcg Medication infusion rate Mcg/kg/min Time from initiation
      of sedation to first airway obstruction Minutes:seconds Obstruction relieved with jaw thrust
      Yes/No Success of JED placement Return of patent airway Time from JED placement to next
      airway manipulation, Minutes:seconds Number of airway manipulations required after JED
      placement counting Frequency of hypoxemia arterial oxygen saturation (SaO2) <90% Duration of
      hypoxemia Minutes:seconds Complications List complications Conversion to GA Yes/No Method of
      GA List method Other airway devices used List device

      4. Investigational Drugs/Devices/Biologics Research: Jaw Elevation Device (JED). The FDA has
      determined the JED is a Class 1 device and thus exempt from 510 K.

      5. Research Material Collected: A data collection form will be filled out by the anesthesia
      provider and returned to an investigator. Information will include details about the
      anesthetic technique used, and the performance of the JED.

      6. Protection of Patient Privacy: All documents relating to an individual's participation in
      this study will be kept in a locked storage. Access to records will be limited to the PI and
      AI's. Computer files containing collected study data will be stored in a password protected
      file system. Identifying information will be recorded on separate form and linked to data
      collection forms with a numbering system, deidentifying the data. Data will be transcribed
      into secured electronic files which will be used for data analysis. Once data analysis is
      complete the data collection sheets will be destroyed or shredded.

      7. Risks: This study confers no additional risk to patients as this in an observational study
      using the JED in a marketed application. All patients in the study will receive the same
      treatment. There are associated risks with receiving deep sedation. These include but are not
      limited to: airway obstruction, need to use other types of airway devices including an
      endotracheal tube, sore throat, nausea and vomiting, aspiration, and other serious, but rare,
      complications (cardiovascular or pulmonary complications). However, these are risks inherent
      to the administration of sedation for your procedure. You would be at risk for these whether
      or not you participated in this study.

      8. Radiation or Laser Exposure: None

      9. Justification of Risks: The JED offers the potential advantage of increasing the range of
      patients who could safely tolerate deep sedation or MAC. By completing this study we hope to
      begin the characterization of populations who can benefit from the use of JED in deep
      sedation or MAC.

      10. Minimization of Risks: By providing a systematic approach to patient selection and data
      collection we hope to gain maximum utility from our study. By performing this study in an
      observational fashion we will allow anesthesia providers to retain full control of anesthetic
      management, for essentially no alteration in the standard of care, and virtually no
      additional clinical risk. Risk of the exposure of PHI will minimized through the methods
      discussed above.
    

Intervention name(s): Jaw Elevation Device (JED)
Intervention type(s): Device
Intervention description(s): apply JED when End tidal O2 low
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult female patients undergoing egg retrieval for infertility requiring deep sedation or
        MAC as their anesthetic method.
      
Keywords: Airway Management; deep sedation; Jaw elevation device