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Trial record 18 of 1688 for:    CARBON DIOXIDE AND dioxide
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Comparison Air Versus Carbon Dioxide Insufflation in Single Balloon Anterograde Enteroscopy

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ClinicalTrials.gov Identifier: NCT03811522
Recruitment Status : Active, not recruiting
First Posted : January 21, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Mercy Health Ohio
Information provided by (Responsible Party):
North Eastern Ohio Gastroenterology and Endoscopy center

Study Description
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Brief Summary:
Observation study comparing patient symptoms of bloating, pain, and nausea between CO2 insufflation vs. O2 insufflation in anterograde balloon enteroscopy.

Condition or disease Intervention/treatment
Carbon Dioxide Insufflation Anterograde Single Balloon Enteroscopy Other: carbon dioxide insufflation Other: Air insufflation

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Study Design
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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

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Groups and Cohorts
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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
 Other: Air insufflation
Receives air insufflation


Outcome Measures
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Primary Outcome Measures :
  1. 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.

    1. Mark your level of pain by drawing a horizontal line on the scale below.
    2. Rate the severity of your nausea by circling a number on the scale.
    3. Rate the severity of your bloating by circling a number on the scale.

    4. 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.


Eligibility Criteria
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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
Study Population
All patients >18 years of age who presented to North Eastern Ohio Gastroenterology and Associates and meet the indications for anterograde or retrograde balloon endoscopy. Indications include small intestinal bleeding, evaluation of small bowel mass, or evaluation and treatment of small bowel strictures. Patients excluded from the study are 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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Ohio
St. Joesph Health Center
Warren, Ohio, United States, 44484
Sponsors and Collaborators
North Eastern Ohio Gastroenterology and Endoscopy center
Mercy Health Ohio
Investigators
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Principal Investigator: Thomas Geisler, D.O. North Eastern Ohio Gastroenterology and Endoscopy center
  Study Documents (Full-Text)

Documents provided by North Eastern Ohio Gastroenterology and Endoscopy center:
Study Protocol and Statistical Analysis Plan  [PDF] January 11, 2019
Informed Consent Form  [PDF] January 11, 2019

More Information
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Publications:

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No