Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy
Condition: Hypoxia; Endoscopy; Anesthesia Morbidity
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      This study is a randomized controlled trial comparing oxygen delivery by nasal mask with
      continuous positive airway pressure versus standard care (nasal cannula or standard facemask)
      during propofol-based sedation for gastrointestinal endoscopy procedures to reduce the
      incidence of hypoxia. The primary outcome will be the rate of oxygen desaturation below 90%
      for ≥15 seconds.
    

Detailed description: 
      This study is a randomized controlled trial comparing oxygen delivery by nasal mask with
      continuous positive airway pressure versus standard care (nasal cannula or standard facemask)
      during propofol-based sedation for gastrointestinal endoscopy procedures to reduce the
      incidence of hypoxia. The primary outcome will be the rate of oxygen desaturation below 90%
      for ≥15 seconds. In addition, secondary measures will include evaluation of mechanism and
      degree of respiratory depression associated with hypoxia and hypoventilation by
      characterizing changes in minute ventilation, tidal volume, and respiratory rate as well as
      the rate and degree of airway obstruction. The investigators hypothesize that the addition of
      nasal continuous positive airway pressure in the intervention arm will lead to decreased
      obstruction as positive pressure will stent open the obstructed airway. Depth of anesthesia
      will be monitored by Bispectral Index and investigators hypothesize that the degree of
      hypoventilation, obstruction, and will be significantly lower in the intervention arm
      compared to the control arm. Further, the depth of anesthesia will be independent of total
      propofol dose received. While the primary outcome in this study is hypoxia, investigators
      also seek to marry end tidal carbon dioxide with minute ventilation and transcutaneous carbon
      dioxide measurement to better understand the total effects of sedation on respiration. Thus
      the study will also serve to evaluate which mode(s) of respiratory monitoring might be the
      best possible intervention to enhance safety during procedural sedation in the future.
      Further, investigators suspect that the amplitude of end tidal carbon dioxide will not
      predict the degree of respiratory depression seen with other monitors. In addition,
      investigators will measure serum short chain fatty acid concentrations as a predictor and
      possible mechanism for differences in individual variability in anesthesia induced
      respiratory depression.
    

Intervention name(s): Nasal Mask; Control: Nasal Cannula
Intervention type(s): Device; Device
Intervention description(s): Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve; Nasal cannula as per usual care
Other intervention name(s): Intervention: Nasal anesthesia mask with positive pressure; Standard Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: procedural sedation; monitored anesthesia care; endoscopy