Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 12/9/2018 |
| Start Date: | October 30, 2017 |
| End Date: | October 30, 2019 |
| Contact: | Laeben Lester, MD |
| Email: | llester4@jhmi.edu |
| Phone: | 410-955-7519 |
A Randomized Controlled Trial of an Intervention to Reduce the Incidence of Hypoxia With Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy
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.
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.
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.
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.
Inclusion Criteria:
- Adult patients (≥ 18 years of age) undergoing colonoscopy, endoscopic
gastroduodenoscopy, and endoscopic gastroduodenoscopy with biopsy and/or ultrasound,
or combined upper and lower endoscopy procedure anticipated to last longer than 10
minutes in the Endoscopy Suite at the Johns Hopkins Hospital when the anesthetic plan
is monitored anesthesia care with propofol-based anesthesia with a natural airway.
Exclusion Criteria:
- Left ventricular Assist Device
- Severe Pulmonary Hypertension
- Ejection fraction less than 35 percent
- Active Congestive Heart Failure Exacerbation
- Planned procedure is Balloon Enteroscopy or Endoscopic Retrograde Duodenoscopy.
- Topical lidocaine administration
- Pregnancy
- Previous enrollment in this study
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