Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy

Not Applicable

Completed

Conditions: Endoscopy
Anesthesia Morbidity
Hypoxia

Interventions: Device: Nasal Mask

Registration Number: NCT03369197

Lead Sponsor: Johns Hopkins University

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 111

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention: Nasal Mask	Nasal Mask	Nasal anesthesia mask with positive pressure

Primary Outcome Measures

Name	Time	Method
Hypoxia Rate as Assessed by Number of Participants With at Least One Hypoxic Event	Approximately 1 hour	Number of subjects undergoing procedural sedation for endoscopy with at least one hypoxic event, defined as oxygen saturation less than 90 percent for 15 seconds.

Secondary Outcome Measures

Name	Time	Method
Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Respiratory Volume Monitoring	Approximately 1 hour	Evaluate hypoventilation by respiratory volume monitoring for minute ventilation. Reported result is the percentage decrease from baseline in minute ventilation.
Depth of Anesthesia in Subjects Undergoing Procedural Sedation for Endoscopy	Approximately 1 hour	Depth of anesthesia by processed electroencephalogram (EEG) bispectral analysis, which is a standard monitor of anesthetic depth using a calibrated dimensionless index that ranges from 0 to 100, with lower numbers corresponding to a deeper anesthetic state.
Total Number of Hypoxic Events in Subjects That Experienced Hypoxia	Approximately 1 hour	In subjects experiencing hypoxia during sedation, the total number of episodes of hypoxia for all participants will be recorded.
Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Transcutaneous Carbon Dioxide Monitoring	Approximately 1 hour	Evaluate hypoventilation in subjects undergoing procedural sedation for endoscopy by transcutaneous carbon dioxide monitoring in millimeters of mercury (mmHg).
Mechanism of Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy and Hypoventilation	Approximately 1 hour	Correlate respiratory volume monitoring transcutaneous carbon dioxide measurement with number of airway maneuvers to identify mechanism of hypoventilation as predominately obstructive or due to respiratory rate or tidal volume.
Hypoxia Duration	Approximately 1 hour	The total time in seconds of oxygen saturation below 90 percent will be recorded