Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy
Primary Purpose
Hypoxia, Endoscopy, Anesthesia Morbidity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nasal Mask
Control: Nasal Cannula
Sponsored by
![Johns Hopkins University](https://trials-media.s3.amazonaws.com/orgs/johns-hopkins-university.jpeg)
About this trial
This is an interventional treatment trial for Hypoxia focused on measuring procedural sedation, monitored anesthesia care, endoscopy
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention: Nasal Mask
Control: Nasal cannula
Arm Description
Nasal anesthesia mask with positive pressure
Nasal Cannula with standard care
Outcomes
Primary Outcome Measures
Hypoxia Rate as Assessed by Number of Participants With at Least One Hypoxic Event
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
Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Transcutaneous Carbon Dioxide Monitoring
Evaluate hypoventilation in subjects undergoing procedural sedation for endoscopy by transcutaneous carbon dioxide monitoring in millimeters of mercury (mmHg).
Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Respiratory Volume Monitoring
Evaluate hypoventilation by respiratory volume monitoring for minute ventilation. Reported result is the percentage decrease from baseline in minute ventilation.
Mechanism of Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy and Hypoventilation
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.
Depth of Anesthesia in Subjects Undergoing Procedural Sedation for Endoscopy
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.
Hypoxia Duration
The total time in seconds of oxygen saturation below 90 percent will be recorded
Total Number of Hypoxic Events in Subjects That Experienced Hypoxia
In subjects experiencing hypoxia during sedation, the total number of episodes of hypoxia for all participants will be recorded.
Full Information
NCT ID
NCT03369197
First Posted
November 28, 2017
Last Updated
October 14, 2022
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT03369197
Brief Title
Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 30, 2017 (Actual)
Primary Completion Date
October 23, 2019 (Actual)
Study Completion Date
October 23, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Endoscopy, Anesthesia Morbidity
Keywords
procedural sedation, monitored anesthesia care, endoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention: Nasal Mask
Arm Type
Experimental
Arm Description
Nasal anesthesia mask with positive pressure
Arm Title
Control: Nasal cannula
Arm Type
Active Comparator
Arm Description
Nasal Cannula with standard care
Intervention Type
Device
Intervention Name(s)
Nasal Mask
Other Intervention Name(s)
Intervention: Nasal anesthesia mask with positive pressure
Intervention Description
Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve
Intervention Type
Device
Intervention Name(s)
Control: Nasal Cannula
Other Intervention Name(s)
Standard Care
Intervention Description
Nasal cannula as per usual care
Primary Outcome Measure Information:
Title
Hypoxia Rate as Assessed by Number of Participants With at Least One Hypoxic Event
Description
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.
Time Frame
Approximately 1 hour
Secondary Outcome Measure Information:
Title
Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Transcutaneous Carbon Dioxide Monitoring
Description
Evaluate hypoventilation in subjects undergoing procedural sedation for endoscopy by transcutaneous carbon dioxide monitoring in millimeters of mercury (mmHg).
Time Frame
Approximately 1 hour
Title
Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Respiratory Volume Monitoring
Description
Evaluate hypoventilation by respiratory volume monitoring for minute ventilation. Reported result is the percentage decrease from baseline in minute ventilation.
Time Frame
Approximately 1 hour
Title
Mechanism of Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy and Hypoventilation
Description
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.
Time Frame
Approximately 1 hour
Title
Depth of Anesthesia in Subjects Undergoing Procedural Sedation for Endoscopy
Description
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.
Time Frame
Approximately 1 hour
Title
Hypoxia Duration
Description
The total time in seconds of oxygen saturation below 90 percent will be recorded
Time Frame
Approximately 1 hour
Title
Total Number of Hypoxic Events in Subjects That Experienced Hypoxia
Description
In subjects experiencing hypoxia during sedation, the total number of episodes of hypoxia for all participants will be recorded.
Time Frame
Approximately 1 hour
Other Pre-specified Outcome Measures:
Title
Short Chain Fatty Acid Concentration
Description
Measure baseline short chain fatty acids in subjects undergoing procedural sedation for endoscopy and correlate the concentration with the degree of respiratory depression by respiratory volume monitoring and transcutaneous carbon dioxide.
Time Frame
Approximately 1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laeben Lester, MD
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy
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