Trial Outcomes & Findings for Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy (NCT NCT03369197)
NCT ID: NCT03369197
Last Updated: 2022-10-18
Results Overview
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.
COMPLETED
NA
111 participants
Approximately 1 hour
2022-10-18
Participant Flow
Patients were recruited in the Endoscopy suite at Johns Hopkins Hospital.
Participant milestones
| Measure |
Intervention: Nasal Mask
Nasal anesthesia mask with positive pressure
Nasal Mask: Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve
|
Control: Nasal Cannula
Nasal Cannula with standard care
Control: Nasal Cannula: Nasal cannula as per usual care
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
58
|
|
Overall Study
COMPLETED
|
53
|
58
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy
Baseline characteristics by cohort
| Measure |
Intervention: Nasal Mask
n=53 Participants
Nasal anesthesia mask with positive pressure
Nasal Mask: Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve
|
Control: Nasal Cannula
n=58 Participants
Nasal Cannula with standard care
Control: Nasal Cannula: Nasal cannula as per usual care
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 1 hourNumber of subjects undergoing procedural sedation for endoscopy with at least one hypoxic event, defined as oxygen saturation less than 90 percent for 15 seconds.
Outcome measures
| Measure |
Intervention: Nasal Mask
n=53 Participants
Nasal anesthesia mask with positive pressure
Nasal Mask: Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve
|
Control: Nasal Cannula
n=58 Participants
Nasal Cannula with standard care
Control: Nasal Cannula: Nasal cannula as per usual care
|
|---|---|---|
|
Hypoxia Rate as Assessed by Number of Participants With at Least One Hypoxic Event
|
3 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Approximately 1 hourPopulation: 11 participants from intervention group and 9 participants from control group were not assessed for this outcome measure.
Evaluate hypoventilation in subjects undergoing procedural sedation for endoscopy by transcutaneous carbon dioxide monitoring in millimeters of mercury (mmHg).
Outcome measures
| Measure |
Intervention: Nasal Mask
n=42 Participants
Nasal anesthesia mask with positive pressure
Nasal Mask: Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve
|
Control: Nasal Cannula
n=48 Participants
Nasal Cannula with standard care
Control: Nasal Cannula: Nasal cannula as per usual care
|
|---|---|---|
|
Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Transcutaneous Carbon Dioxide Monitoring
|
53.3 mmHg
Standard Deviation 6.20
|
51.9 mmHg
Standard Deviation 8.14
|
SECONDARY outcome
Timeframe: Approximately 1 hourPopulation: Only 43 in the intervention group and 40 in the control group had sufficient data to be analyzed.
Evaluate hypoventilation by respiratory volume monitoring for minute ventilation. Reported result is the percentage decrease from baseline in minute ventilation.
Outcome measures
| Measure |
Intervention: Nasal Mask
n=43 Participants
Nasal anesthesia mask with positive pressure
Nasal Mask: Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve
|
Control: Nasal Cannula
n=40 Participants
Nasal Cannula with standard care
Control: Nasal Cannula: Nasal cannula as per usual care
|
|---|---|---|
|
Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Respiratory Volume Monitoring
|
64 percentage of decrease
Standard Deviation 21.9
|
59 percentage of decrease
Standard Deviation 22
|
SECONDARY outcome
Timeframe: Approximately 1 hourPopulation: This data was not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 1 hourPopulation: 5 participants from intervention group and 7 participants from control group were not assessed for this outcome measure.
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.
Outcome measures
| Measure |
Intervention: Nasal Mask
n=48 Participants
Nasal anesthesia mask with positive pressure
Nasal Mask: Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve
|
Control: Nasal Cannula
n=50 Participants
Nasal Cannula with standard care
Control: Nasal Cannula: Nasal cannula as per usual care
|
|---|---|---|
|
Depth of Anesthesia in Subjects Undergoing Procedural Sedation for Endoscopy
|
40.19 score on a scale
Standard Deviation 13.64
|
40.30 score on a scale
Standard Deviation 15.07
|
SECONDARY outcome
Timeframe: Approximately 1 hourPopulation: This data was not collected.
The total time in seconds of oxygen saturation below 90 percent will be recorded
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 1 hourPopulation: The 3 patients in nasal mask arm and 16 in nasal cannula arm experienced hypoxia.
In subjects experiencing hypoxia during sedation, the total number of episodes of hypoxia for all participants will be recorded.
Outcome measures
| Measure |
Intervention: Nasal Mask
n=3 Participants
Nasal anesthesia mask with positive pressure
Nasal Mask: Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve
|
Control: Nasal Cannula
n=16 Participants
Nasal Cannula with standard care
Control: Nasal Cannula: Nasal cannula as per usual care
|
|---|---|---|
|
Total Number of Hypoxic Events in Subjects That Experienced Hypoxia
|
4 hypoxic events
|
23 hypoxic events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 1 hourMeasure 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.
Outcome measures
Outcome data not reported
Adverse Events
Intervention: Nasal Mask
Control: Nasal Cannula
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place