Comparison Air Versus Carbon Dioxide Insufflation in Single Balloon Anterograde Enteroscopy
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03811522 |
Recruitment Status :
Active, not recruiting
First Posted : January 21, 2019
Last Update Posted : February 15, 2019
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Condition or disease | Intervention/treatment |
---|---|
Carbon Dioxide Insufflation Anterograde Single Balloon Enteroscopy | Other: carbon dioxide insufflation Other: Air insufflation |

Study Type : | Observational |
Estimated Enrollment : | 50 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | Comparison Air Versus Carbon Dioxide Insufflation in Single Balloon Anterograde Enteroscopy |
Actual Study Start Date : | January 1, 2019 |
Estimated Primary Completion Date : | May 1, 2020 |
Estimated Study Completion Date : | June 1, 2020 |

Group/Cohort | Intervention/treatment |
---|---|
Carbon Dioxide Insufflation
Received CO2 insufflation during procedure
|
Other: carbon dioxide insufflation
Receives CO2 insufflation |
Air Sufflation
Received ambient insufflation during procedure
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Other: Air insufflation
Receives air insufflation |
- The reduction of post operational pain [ Time Frame: the survey will be asked at 15minutes, 30minutes, 1hour, and 24hours post op. ]
Assessment of post operational pain will be made by the the horizontal assessment scale (HAS) for post operative pain. The survey will include the following questions.
- Mark your level of pain by drawing a horizontal line on the scale below.
- Rate the severity of your nausea by circling a number on the scale.
- Rate the severity of your bloating by circling a number on the scale.
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Rate the severity of your abdominal fullness by circling a number on the scale.
- Note the scale was not provided given the limitation of characters.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- All patients who presented to North Eastern Ohio Gastroenterology and Associates and meet the indications for anterograde single balloon endoscopy. Indications include small intestinal bleeding, evaluation of small bowel mass, or evaluation and treatment of small bowel strictures.
Exclusion Criteria:
- Those who wish not to participate, pregnant patients, mentally disabled individuals, prisoners, patients who have long-term analgesic use (greater than 3 months) in the past 6 months from procedure date, or those patients deemed too high risk to undergo balloon endoscopy. High risk, defined as have 3 or more of the following risk factors: chronic obstructive pulmonary disease, renal failure, morbid obesity (BMI > 40), immuno-suppression, acquired/concurrent infection, diabetes, and chronic steroid use.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811522
United States, Ohio | |
St. Joesph Health Center | |
Warren, Ohio, United States, 44484 |
Principal Investigator: | Thomas Geisler, D.O. | North Eastern Ohio Gastroenterology and Endoscopy center |
Documents provided by North Eastern Ohio Gastroenterology and Endoscopy center:
Publications:
Responsible Party: | North Eastern Ohio Gastroenterology and Endoscopy center |
ClinicalTrials.gov Identifier: | NCT03811522 History of Changes |
Other Study ID Numbers: |
NEOGastro |
First Posted: | January 21, 2019 Key Record Dates |
Last Update Posted: | February 15, 2019 |
Last Verified: | February 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |