Trial Outcomes & Findings for Is End Tidal CO2 Level Elevation During Upper Endoscopy With CO2 Gas Insufflation Physiologically Significant (NCT NCT04541667)
NCT ID: NCT04541667
Last Updated: 2023-10-10
Results Overview
Compare the peak end-tidal CO2 levels (\>/= 60 mmHg) observed during endoscopy in children managed with endotracheal intubation or laryngeal mask airway using CO2 versus air
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
Measured from time of procedure start to time of procedure conclusion this lasts usually from 1-2.5 hours.
Results posted on
2023-10-10
Participant Flow
1 participant who consented withdrew consent prior to randomization. Therefore, this patient did not undergo randomization
Unit of analysis: Procedures
Participant milestones
| Measure |
Air for Luminal Inflation
Patients randomized into this arm will have luminal inflation using air.
Air: Air will be used for luminal inflation.
|
Carbon Dioxide for Luminal Inflation
Patients randomized into this arm will have luminal inflation using carbon dioxide.
Carbon Dioxide: Carbon dioxide will be used for luminal inflation.
|
|---|---|---|
|
Overall Study
STARTED
|
98 98
|
102 102
|
|
Overall Study
COMPLETED
|
98 98
|
102 102
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Is End Tidal CO2 Level Elevation During Upper Endoscopy With CO2 Gas Insufflation Physiologically Significant
Baseline characteristics by cohort
| Measure |
Air for Luminal Inflation
n=98 Procedures
Patients randomized into this arm will have luminal inflation using air.
Air: Air will be used for luminal inflation.
|
Carbon Dioxide for Luminal Inflation
n=102 Procedures
Patients randomized into this arm will have luminal inflation using carbon dioxide.
Carbon Dioxide: Carbon dioxide will be used for luminal inflation.
|
Total
n=200 Procedures
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12 years
n=5 Participants
|
12 years
n=7 Participants
|
12 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Procedures
n=46 Procedures
|
56 Procedures
n=54 Procedures
|
114 Procedures
n=100 Procedures
|
|
Sex: Female, Male
Male
|
40 Procedures
n=46 Procedures
|
46 Procedures
n=54 Procedures
|
86 Procedures
n=100 Procedures
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Procedures
n=46 Procedures
|
6 Procedures
n=54 Procedures
|
12 Procedures
n=100 Procedures
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
92 Procedures
n=46 Procedures
|
96 Procedures
n=54 Procedures
|
188 Procedures
n=100 Procedures
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Procedures
n=46 Procedures
|
0 Procedures
n=54 Procedures
|
0 Procedures
n=100 Procedures
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Procedures
n=46 Procedures
|
0 Procedures
n=54 Procedures
|
0 Procedures
n=100 Procedures
|
|
Race (NIH/OMB)
Asian
|
0 Procedures
n=46 Procedures
|
0 Procedures
n=54 Procedures
|
0 Procedures
n=100 Procedures
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Procedures
n=46 Procedures
|
0 Procedures
n=54 Procedures
|
0 Procedures
n=100 Procedures
|
|
Race (NIH/OMB)
Black or African American
|
1 Procedures
n=46 Procedures
|
0 Procedures
n=54 Procedures
|
1 Procedures
n=100 Procedures
|
|
Race (NIH/OMB)
White
|
84 Procedures
n=46 Procedures
|
84 Procedures
n=54 Procedures
|
168 Procedures
n=100 Procedures
|
|
Race (NIH/OMB)
More than one race
|
6 Procedures
n=46 Procedures
|
10 Procedures
n=54 Procedures
|
16 Procedures
n=100 Procedures
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Procedures
n=46 Procedures
|
8 Procedures
n=54 Procedures
|
15 Procedures
n=100 Procedures
|
|
Region of Enrollment
United States
|
98 participants
n=5 Participants
|
102 participants
n=7 Participants
|
200 participants
n=5 Participants
|
|
BMI z score
|
0.23 units on a scale
n=5 Participants
|
0.61 units on a scale
n=7 Participants
|
0.23 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured from time of procedure start to time of procedure conclusion this lasts usually from 1-2.5 hours.Population: Participants in this groups refers to procedures. Procedure count was used for analysis and not participant count
Compare the peak end-tidal CO2 levels (\>/= 60 mmHg) observed during endoscopy in children managed with endotracheal intubation or laryngeal mask airway using CO2 versus air
Outcome measures
| Measure |
Air for Luminal Inflation
n=98 Procedures
Procedures randomized into this arm will have luminal inflation using air.
Air: Air will be used for luminal inflation.
|
Carbon Dioxide for Luminal Inflation
n=102 Procedures
Procedures randomized into this arm will have luminal inflation using carbon dioxide.
Carbon Dioxide: Carbon dioxide will be used for luminal inflation.
|
|---|---|---|
|
Number of Procedures With Elevated End-tidal CO2 Levels
|
8 Procedures
|
21 Procedures
|
SECONDARY outcome
Timeframe: This will be assessed before and after the procedurePopulation: Participant procedures randomized into air or CO2 for endoscopic insufflation. Participants reporting abdominal pain after procedure. Higher numbers are worse
Pain rating scales using FLACC and VAS will be used to assess self reported pain before and after the procedure
Outcome measures
| Measure |
Air for Luminal Inflation
n=97 Participants
Procedures randomized into this arm will have luminal inflation using air.
Air: Air will be used for luminal inflation.
|
Carbon Dioxide for Luminal Inflation
n=102 Participants
Procedures randomized into this arm will have luminal inflation using carbon dioxide.
Carbon Dioxide: Carbon dioxide will be used for luminal inflation.
|
|---|---|---|
|
Number of Participants Reporting Abdominal Pain
|
14 participants
|
15 participants
|
Adverse Events
Air for Luminal Inflation
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Carbon Dioxide for Luminal Inflation
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Air for Luminal Inflation
n=98 participants at risk
Patients randomized into this arm will have luminal inflation using air.
Air: Air will be used for luminal inflation.
|
Carbon Dioxide for Luminal Inflation
n=102 participants at risk
Patients randomized into this arm will have luminal inflation using carbon dioxide.
Carbon Dioxide: Carbon dioxide will be used for luminal inflation.
|
|---|---|---|
|
Vascular disorders
Hypotension
|
2.0%
2/98 • Procedure duration which lasts between 1-2.5 hours
Procedure related adverse events such as bleeding and perforation Anesthesia related adverse events such as hypotension, hypertension, tachypnea
|
2.9%
3/102 • Procedure duration which lasts between 1-2.5 hours
Procedure related adverse events such as bleeding and perforation Anesthesia related adverse events such as hypotension, hypertension, tachypnea
|
|
Vascular disorders
Hypertension
|
2.0%
2/98 • Procedure duration which lasts between 1-2.5 hours
Procedure related adverse events such as bleeding and perforation Anesthesia related adverse events such as hypotension, hypertension, tachypnea
|
2.0%
2/102 • Procedure duration which lasts between 1-2.5 hours
Procedure related adverse events such as bleeding and perforation Anesthesia related adverse events such as hypotension, hypertension, tachypnea
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
1.0%
1/98 • Procedure duration which lasts between 1-2.5 hours
Procedure related adverse events such as bleeding and perforation Anesthesia related adverse events such as hypotension, hypertension, tachypnea
|
0.00%
0/102 • Procedure duration which lasts between 1-2.5 hours
Procedure related adverse events such as bleeding and perforation Anesthesia related adverse events such as hypotension, hypertension, tachypnea
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place