Comparison Air Versus Carbon Dioxide Insufflation in Single Balloon Anterograde Enteroscopy

NCT03811522 | Unknown

• 1 other identifier: NEOGastro
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carbon Dioxide Insufflation; Anterograde Single Balloon Enteroscopy

Outcome Measures

Primary Outcomes (1)

• The reduction of post operational pain

  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.

  the survey will be asked at 15minutes, 30minutes, 1hour, and 24hours post op.

Study Arms (2)

Carbon Dioxide Insufflation

Received CO2 insufflation during procedure

Other: carbon dioxide insufflation

Air Sufflation

Received ambient insufflation during procedure

Other: Air insufflation

Interventions

carbon dioxide insufflation OTHER

Receives CO2 insufflation

Carbon Dioxide Insufflation

Air insufflation OTHER

Receives air insufflation

Air Sufflation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• North Eastern Ohio Gastroenterology and Endoscopy center: lead
• Mercy Health Ohio: collaborator

Study Sites (1)

St. Joesph Health Center

Warren, Ohio, 44484, United States

Location

Related Publications (9)

• Sajid MS, Caswell J, Bhatti MI, Sains P, Baig MK, Miles WF. Carbon dioxide insufflation vs conventional air insufflation for colonoscopy: a systematic review and meta-analysis of published randomized controlled trials. Colorectal Dis. 2015 Feb;17(2):111-23. doi: 10.1111/codi.12837.

  PMID: 25393051 BACKGROUND

• Fernandez-Calderon M, Munoz-Navas MA, Carrascosa-Gil J, Betes-Ibanez MT, de-la-Riva S, Prieto-de-Frias C, Herraiz-Bayod MT, Carretero-Ribon C. Carbon dioxide vs. air insufflation in ileo-colonoscopy and in gastroscopy plus ileo-colonoscopy: a comparative study. Rev Esp Enferm Dig. 2012 May;104(5):237-41. doi: 10.4321/s1130-01082012000500003.

  PMID: 22662775 BACKGROUND

• ASGE Technology Committee; Lo SK, Fujii-Lau LL, Enestvedt BK, Hwang JH, Konda V, Manfredi MA, Maple JT, Murad FM, Pannala R, Woods KL, Banerjee S. The use of carbon dioxide in gastrointestinal endoscopy. Gastrointest Endosc. 2016 May;83(5):857-65. doi: 10.1016/j.gie.2016.01.046. Epub 2016 Mar 3. No abstract available.

  PMID: 26946413 BACKGROUND

• Riverso M, Perbtani YB, Shuster JJD, Chakraborty J, Brar TS, Agarwal M, Zhang H, Gupte A, Chauhan SS, Forsmark CE, Draganov PV, Yang D. Carbon dioxide insufflation is associated with increased serrated polyp detection rate when compared to room air insufflation during screening colonoscopy. Endosc Int Open. 2017 Sep;5(9):E905-E912. doi: 10.1055/s-0043-116382. Epub 2017 Sep 13.

  PMID: 28924598 BACKGROUND

• Yasumasa K, Nakajima K, Endo S, Ito T, Matsuda H, Nishida T. Carbon dioxide insufflation attenuates parietal blood flow obstruction in distended colon: potential advantages of carbon dioxide insufflated colonoscopy. Surg Endosc. 2006 Apr;20(4):587-94. doi: 10.1007/s00464-005-0252-0. Epub 2006 Jan 25.

  PMID: 16437273 BACKGROUND

• Stavropoulos SN, Desilets DJ, Fuchs KH, Gostout CJ, Haber G, Inoue H, Kochman ML, Modayil R, Savides T, Scott DJ, Swanstrom LL, Vassiliou MC. Per-oral endoscopic myotomy white paper summary. Surg Endosc. 2014 Jul;28(7):2005-19. doi: 10.1007/s00464-014-3630-7. Epub 2014 Jun 17. No abstract available.

  PMID: 24935204 BACKGROUND

• Navarro-Ripoll R, Martinez-Palli G, Guarner-Argente C, Cordova H, Martinez-Zamora MA, Comas J, Rodriguez de Miguel C, Beltran M, Rodriguez-D'Jesus A, Hernandez-Cera C, Llach J, Balust J, Fernandez-Esparrach G. On-demand endoscopic CO2 insufflation with feedback pressure regulation during natural orifice transluminal endoscopic surgery (NOTES) peritoneoscopy induces minimal hemodynamic and respiratory changes. Gastrointest Endosc. 2012 Aug;76(2):388-95. doi: 10.1016/j.gie.2011.10.015.

  PMID: 22817790 BACKGROUND

• Li X, Zhao YJ, Dai J, Li XB, Xue HB, Zhang Y, Xiong GS, Ohtsuka K, Gao YJ, Liu Q, Song Y, Fang JY, Ge ZZ. Carbon dioxide insufflation improves the intubation depth and total enteroscopy rate in single-balloon enteroscopy: a randomised, controlled, double-blind trial. Gut. 2014 Oct;63(10):1560-5. doi: 10.1136/gutjnl-2013-306069. Epub 2014 Mar 13.

  PMID: 24626435 BACKGROUND

• Lenz P, Meister T, Manno M, Pennazio M, Conigliaro R, Lebkucher S, Ullerich H, Schmedt A, Floer M, Beyna T, Lenze F, Domagk D. CO2 insufflation during single-balloon enteroscopy: a multicenter randomized controlled trial. Endoscopy. 2014 Jan;46(1):53-8. doi: 10.1055/s-0033-1359041. Epub 2013 Dec 18.

  PMID: 24353124 BACKGROUND

Study Officials

• Thomas Geisler, D.O.

  North Eastern Ohio Gastroenterology and Endoscopy center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 22, 2019
• Study Start: January 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: June 1, 2020
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)