An interventional study of Air and Carbon Dioxide in Endoscopy, sponsored by University of Nebraska. Completed at 1 site in United States. Open to participants aged 6 Months to 19 Years. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by University of Nebraska · Not applicable, Interventional, and Treatment
During the course of an endoscopic procedure, air has historically been used to inflate the lumen to provide adequate visualization and allow for the endoscope to advance as necessary. In many adult centers, carbon dioxide is used for insufflation for all procedures. Many pediatric centers have started using carbon dioxide for insufflation during endoscopy based on the adult studies. Few pediatric studies have been done. This study is designed to test whether carbon dioxide is associated with any negative, post-procedural, outcomes in pediatric patients.
Luminal inflation is essential for adequate visualization and endoscope advancement during endoscopy. Although air has previously been the standard gas used, CO2 is increasing preferred in adult endoscopy centers, due to reports of decreased post-procedural abdominal discomfort compared to air. Few published studies in children demonstrated decreased abdominal discomfort with use of CO2, but safety concerns for its use in pediatric endoscopy remain.
This is a Double-blinded, prospective, randomized study of all pediatric patients undergoing procedures involving upper endoscopy in the Childrens Hospital \& Medical Center. Randomization will be for patients undergoing upper endoscopy related procedures. Patients will be randomized 1:1 for air or CO2. Vital signs will be recorded before the procedure, throughout the procedure and after the procedure until fully awake. While in the procedure room, end-tidal CO2 level will be continuously recorded.
University of Nebraska is the lead sponsor of 473 studies on the registry; 66 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients randomized into this arm will have luminal inflation using air.
Other: Air
Patients randomized into this arm will have luminal inflation using carbon dioxide.
Other: Carbon Dioxide
Air will be used for luminal inflation.
Also known as: Gas
Carbon dioxide will be used for luminal inflation.
Also known as: Gas
Number of Procedures With Elevated End-tidal CO2 Levels
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
Time frame: Measured from time of procedure start to time of procedure conclusion this lasts usually from 1-2.5 hours.
Number of Participants Reporting Abdominal Pain
Pain rating scales using FLACC and VAS will be used to assess self reported pain before and after the procedure
Time frame: This will be assessed before and after the procedure
| Milestone | Air for Luminal Inflation | Carbon Dioxide for Luminal Inflation |
|---|---|---|
| Started | 98 | 102 |
| Completed | 98 | 102 |
| Not completed | 0 | 0 |
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
| Procedures | Air for Luminal Inflation | Carbon Dioxide for Luminal Inflation |
|---|---|---|
| Number of Procedures With Elevated End-tidal CO2 Levels | 8 | 21 |
Pain rating scales using FLACC and VAS will be used to assess self reported pain before and after the procedure
| participants | Air for Luminal Inflation | Carbon Dioxide for Luminal Inflation |
|---|---|---|
| Number of Participants Reporting Abdominal Pain | 14 | 15 |
Collected over Procedure duration which lasts between 1-2.5 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Air for Luminal Inflation | 0/98 (0%) | 0/98 (0%) | 5/98 (5.1%) |
| Carbon Dioxide for Luminal Inflation | 0/102 (0%) | 0/102 (0%) | 5/102 (4.9%) |
| Event | Air for Luminal Inflation | Carbon Dioxide for Luminal Inflation |
|---|---|---|
| HypotensionVascular disorders | 2/98 | 3/102 |
| HypertensionVascular disorders | 2/98 | 2/102 |
| TachypneaRespiratory, thoracic and mediastinal disorders | 1/98 | 0/102 |
Population was mostly female, Caucasians and older children
| Age, Continuous(years) | Air for Luminal Inflation | Carbon Dioxide for Luminal Inflation | Total |
|---|---|---|---|
| Median | 12 (0 to 19) | 12 (1 to 19) | 12 (0 to 19) |
| Sex: Female, Male(Procedures) | Air for Luminal Inflation | Carbon Dioxide for Luminal Inflation | Total |
|---|---|---|---|
| Female | 58 | 56 | 114 |
| Male | 40 | 46 | 86 |
| Ethnicity (NIH/OMB)(Procedures) | Air for Luminal Inflation | Carbon Dioxide for Luminal Inflation | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 6 | 12 |
| Not Hispanic or Latino | 92 | 96 | 188 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Procedures) | Air for Luminal Inflation | Carbon Dioxide for Luminal Inflation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 84 | 84 | 168 |
| More than one race | 6 | 10 | 16 |
| Unknown or Not Reported | 7 | 8 | 15 |
| Region of Enrollment(participants) | Air for Luminal Inflation | Carbon Dioxide for Luminal Inflation | Total |
|---|---|---|---|
| United States | 98 | 102 | 200 |
| BMI z score(units on a scale) | Air for Luminal Inflation | Carbon Dioxide for Luminal Inflation | Total |
|---|---|---|---|
| Median | 0.23 (-3.86 to 2.94) | 0.61 (-2.90 to 2.72) | 0.23 (-3.86 to 2.94) |
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