<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03811522</url>
  </required_header>
  <id_info>
    <org_study_id>NEOGastro</org_study_id>
    <nct_id>NCT03811522</nct_id>
  </id_info>
  <brief_title>Comparison Air Versus Carbon Dioxide Insufflation in Single Balloon Anterograde Enteroscopy</brief_title>
  <official_title>Comparison Air Versus Carbon Dioxide Insufflation in Single Balloon Anterograde Enteroscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>North Eastern Ohio Gastroenterology and Endoscopy center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mercy Health Ohio</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>North Eastern Ohio Gastroenterology and Endoscopy center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Observation study comparing patient symptoms of bloating, pain, and nausea between CO2&#xD;
      insufflation vs. O2 insufflation in anterograde balloon enteroscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Subjects:&#xD;
&#xD;
      Patients &gt;18 years of age who presented to North Eastern Ohio Gastroenterology and Associates&#xD;
      and meet the indications for anterograde or retrograde balloon endoscopy. Indications include&#xD;
      small intestinal bleeding, evaluation of small bowel mass, or evaluation and treatment of&#xD;
      small bowel strictures. Patients excluded from the study are those who wish not to&#xD;
      participate, pregnant patients, mentally disabled individuals, prisoners, patients who have&#xD;
      long-term analgesic use (greater than 3 months) in the past 6 months from procedure date, or&#xD;
      those patients deemed too high risk to undergo balloon endoscopy. High risk patients will be&#xD;
      defined as have 3 or more of the following risk factors: chronic obstructive pulmonary&#xD;
      disease, renal failure, morbid obesity (BMI &gt; 40), immunosuppression, acquired/concurrent&#xD;
      infection, diabetes, and chronic steroid use. Pre-operative risk will also be assessed by Dr.&#xD;
      Dodig and GI fellow. ASA classifications will be evaluated on every patient by St. Joseph's&#xD;
      staff anesthesiologist. Given that the patient is receiving general anesthesia, it is&#xD;
      hospital policy that they are evaluated at the hospital by anesthesia team prior to the&#xD;
      procedure for assessment of risk. Should a patient elect not to participate in the study they&#xD;
      will receive the standard of care.&#xD;
&#xD;
      Subject Recruitment/Screening/Consent:&#xD;
&#xD;
      Patients will be recruited/consented/randomized by the GI fellow and advanced anterograde&#xD;
      balloon endoscopist during the patient's routine office visit to discuss their pending&#xD;
      procedure. This will take place in a private consultation room to ensure privacy and should&#xD;
      take approximately 10-15 minutes. In order to minimize coercion, it will be made very clear&#xD;
      to patients that their participation is voluntary and that participation will in no way&#xD;
      affect their future care. Randomization will be performed using a sealed envelope system. All&#xD;
      patients are to receive a copy of the informed consent.&#xD;
&#xD;
      Study Procedures:&#xD;
&#xD;
      The single balloon enteroscopy is performed with Olympus (SIF-Q180) and operated by a single&#xD;
      experienced endoscopist, Dr. Milan Dodig, with over 1,000 single balloon endoscopies have&#xD;
      been performed. Additional assistance provided via 3 gastroenterology fellows (Ryan Carbaugh&#xD;
      D.O., Thomas Geisler D.O., and Justin Cochran D.O.). All anterograde enteroscopy procedures&#xD;
      are to be performed in the surgical suite with general anesthesia. Patient CO2 levels will be&#xD;
      non-invasively monitored by anesthesia with End-Tidal Carbon Dioxide (ETCO2). Anesthesia will&#xD;
      be administered at the discretion of the consulting anesthesiologist via fentanyl, versed,&#xD;
      and propofol. Insufflation utilized during procedure determined via randomization to air or&#xD;
      carbon dioxide prior to procedure. The rate of air or carbon dioxide (level) is left to&#xD;
      discretion of acting endoscopists for proper insufflation of bowel to achieve adequate&#xD;
      luminal views. CO2 insufflator to be used is a Stratus CO2 insufflator made by Medivators.&#xD;
&#xD;
      After completion of procedure determination of patient pain level will be assessed at 15&#xD;
      minutes, 30 minutes, and 1-hour and 24-hour intervals using a patient survey. Pain is&#xD;
      assessed based on the horizontal assessment scale (HAS). This scale based on a horizontal&#xD;
      line measuring 100mm in length. Patient will be asked at the afore mentioned time intervals&#xD;
      to mark with pen their level of pain on the HAS. The mark will then be measured in&#xD;
      millimeters to determine score of pain. Score will be in a range from 0 to 100mm. Zero being&#xD;
      no pain at all and 100mm the maximum pain level. The HAS is then documented with type of&#xD;
      insufflation utilized and time interval. Patient will also be asked about nausea, abdominal&#xD;
      fullness, and bloating after procedure to be ranked on a 0 to 10 scale, with zero being&#xD;
      nothing to 10 as severe. This will also be ascertained at 15 minutes, 30 minutes, 1 hours and&#xD;
      24 hours. The 24 hours assessment for pain as well as dyspepsia symptoms is achieved through&#xD;
      patients receiving HAS scale along with a questionnaire asking to rank dyspeptic symptoms.&#xD;
      The HAS scale and dyspeptic questionnaire will be marked with patient identification number.&#xD;
      A self-address envelope with postage will be given to patient with instruction return once&#xD;
      completed within 24 hours of original procedure. Instruction sheets along with how to take&#xD;
      dyspeptic survey will also be given.&#xD;
&#xD;
      Statistical Methods:&#xD;
&#xD;
      Data will be entered into Microsoft Excel 2017 and SPSS version 22 statistical programs.&#xD;
      Analysis will include descriptive statistics, t-test, standard error, Pearson and fisher&#xD;
      exact test. Statistical significance will be established with an alpha of 0.05 for all&#xD;
      comparisons.&#xD;
&#xD;
      Adverse Events:&#xD;
&#xD;
      Risks consist of those entailed with general anesthesia and single balloon endoscopy.&#xD;
&#xD;
      The risk of CO2 insufflation consists of respiratory depression and CO2 embolism.16&#xD;
&#xD;
      Recording of Adverse Events:&#xD;
&#xD;
      At each contact with the subject, the investigator will seek information on adverse events by&#xD;
      specific questioning and, as appropriate, by examination. Information on all adverse events&#xD;
      will be recorded immediately (e.g., signs, symptoms, abnormal diagnostic procedures). The&#xD;
      clinical course of each event will be followed until resolution, stabilization, or until it&#xD;
      has been determined that the study treatment or participation is not the cause.&#xD;
&#xD;
      Reporting of Serious Adverse Events Reports of all serious adverse events (including&#xD;
      follow-up information) will be submitted to the St. Elizabeth's Mercy Health IRB within five&#xD;
      business days.&#xD;
&#xD;
      Data Management and Confidentiality Patient data will be entered into electronic&#xD;
      spreadsheets. The spreadsheet will be stored as separate file, protected by unique passwords.&#xD;
      Only the investigators will have access to the files and their passwords. Paper records will&#xD;
      be stored in hard copy in a locked filing cabinet in the investigator's office or at the&#xD;
      hospital's endoscopy suit. Should any new significant findings be made during the study, the&#xD;
      patient will be made privy to these findings in a timely manner.&#xD;
&#xD;
      Provisions to Protect the Privacy Interests of Subjects Patient consent and all other&#xD;
      research related activities will take place in a private exam room. Patient will also be&#xD;
      receiving a copy of their informed consent.&#xD;
&#xD;
      Funding Source:&#xD;
&#xD;
      No funding is being sought for this study or being received.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">June 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The reduction of post operational pain</measure>
    <time_frame>the survey will be asked at 15minutes, 30minutes, 1hour, and 24hours post op.</time_frame>
    <description>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.&#xD;
Mark your level of pain by drawing a horizontal line on the scale below.&#xD;
Rate the severity of your nausea by circling a number on the scale.&#xD;
Rate the severity of your bloating by circling a number on the scale.&#xD;
Rate the severity of your abdominal fullness by circling a number on the scale.&#xD;
Note the scale was not provided given the limitation of characters.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Carbon Dioxide Insufflation</condition>
  <condition>Anterograde Single Balloon Enteroscopy</condition>
  <arm_group>
    <arm_group_label>Carbon Dioxide Insufflation</arm_group_label>
    <description>Received CO2 insufflation during procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Air Sufflation</arm_group_label>
    <description>Received ambient insufflation during procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>carbon dioxide insufflation</intervention_name>
    <description>Receives CO2 insufflation</description>
    <arm_group_label>Carbon Dioxide Insufflation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Air insufflation</intervention_name>
    <description>Receives air insufflation</description>
    <arm_group_label>Air Sufflation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients &gt;18 years of age who presented to North Eastern Ohio Gastroenterology and&#xD;
        Associates and meet the indications for anterograde or retrograde balloon endoscopy.&#xD;
        Indications include small intestinal bleeding, evaluation of small bowel mass, or&#xD;
        evaluation and treatment of small bowel strictures. Patients excluded from the study are&#xD;
        those who wish not to participate, pregnant patients, mentally disabled individuals,&#xD;
        prisoners, patients who have long-term analgesic use (greater than 3 months) in the past 6&#xD;
        months from procedure date, or those patients deemed too high risk to undergo balloon&#xD;
        endoscopy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients who presented to North Eastern Ohio Gastroenterology and Associates and&#xD;
             meet the indications for anterograde single balloon endoscopy. Indications include&#xD;
             small intestinal bleeding, evaluation of small bowel mass, or evaluation and treatment&#xD;
             of small bowel strictures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who wish not to participate, pregnant patients, mentally disabled individuals,&#xD;
             prisoners, patients who have long-term analgesic use (greater than 3 months) in the&#xD;
             past 6 months from procedure date, or those patients deemed too high risk to undergo&#xD;
             balloon endoscopy. High risk, defined as have 3 or more of the following risk factors:&#xD;
             chronic obstructive pulmonary disease, renal failure, morbid obesity (BMI &gt; 40),&#xD;
             immuno-suppression, acquired/concurrent infection, diabetes, and chronic steroid use.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Geisler, D.O.</last_name>
    <role>Principal Investigator</role>
    <affiliation>North Eastern Ohio Gastroenterology and Endoscopy center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Joesph Health Center</name>
      <address>
        <city>Warren</city>
        <state>Ohio</state>
        <zip>44484</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>25393051</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22662775</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26946413</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>28924598</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16437273</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24935204</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22817790</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24626435</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24353124</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>February 13, 2019</last_update_submitted>
  <last_update_submitted_qc>February 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 11, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT03811522/Prot_SAP_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 11, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT03811522/ICF_004.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03811522
org study id: NEOGastro
nct id: NCT03811522
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Observation study comparing patient symptoms of bloating, pain, and nausea between CO2
      insufflation vs. O2 insufflation in anterograde balloon enteroscopy.
Study Subjects:

      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. High risk patients will be
      defined as have 3 or more of the following risk factors: chronic obstructive pulmonary
      disease, renal failure, morbid obesity (BMI > 40), immunosuppression, acquired/concurrent
      infection, diabetes, and chronic steroid use. Pre-operative risk will also be assessed by Dr.
      Dodig and GI fellow. ASA classifications will be evaluated on every patient by St. Joseph's
      staff anesthesiologist. Given that the patient is receiving general anesthesia, it is
      hospital policy that they are evaluated at the hospital by anesthesia team prior to the
      procedure for assessment of risk. Should a patient elect not to participate in the study they
      will receive the standard of care.

      Subject Recruitment/Screening/Consent:

      Patients will be recruited/consented/randomized by the GI fellow and advanced anterograde
      balloon endoscopist during the patient's routine office visit to discuss their pending
      procedure. This will take place in a private consultation room to ensure privacy and should
      take approximately 10-15 minutes. In order to minimize coercion, it will be made very clear
      to patients that their participation is voluntary and that participation will in no way
      affect their future care. Randomization will be performed using a sealed envelope system. All
      patients are to receive a copy of the informed consent.

      Study Procedures:

      The single balloon enteroscopy is performed with Olympus (SIF-Q180) and operated by a single
      experienced endoscopist, Dr. Milan Dodig, with over 1,000 single balloon endoscopies have
      been performed. Additional assistance provided via 3 gastroenterology fellows (Ryan Carbaugh
      D.O., Thomas Geisler D.O., and Justin Cochran D.O.). All anterograde enteroscopy procedures
      are to be performed in the surgical suite with general anesthesia. Patient CO2 levels will be
      non-invasively monitored by anesthesia with End-Tidal Carbon Dioxide (ETCO2). Anesthesia will
      be administered at the discretion of the consulting anesthesiologist via fentanyl, versed,
      and propofol. Insufflation utilized during procedure determined via randomization to air or
      carbon dioxide prior to procedure. The rate of air or carbon dioxide (level) is left to
      discretion of acting endoscopists for proper insufflation of bowel to achieve adequate
      luminal views. CO2 insufflator to be used is a Stratus CO2 insufflator made by Medivators.

      After completion of procedure determination of patient pain level will be assessed at 15
      minutes, 30 minutes, and 1-hour and 24-hour intervals using a patient survey. Pain is
      assessed based on the horizontal assessment scale (HAS). This scale based on a horizontal
      line measuring 100mm in length. Patient will be asked at the afore mentioned time intervals
      to mark with pen their level of pain on the HAS. The mark will then be measured in
      millimeters to determine score of pain. Score will be in a range from 0 to 100mm. Zero being
      no pain at all and 100mm the maximum pain level. The HAS is then documented with type of
      insufflation utilized and time interval. Patient will also be asked about nausea, abdominal
      fullness, and bloating after procedure to be ranked on a 0 to 10 scale, with zero being
      nothing to 10 as severe. This will also be ascertained at 15 minutes, 30 minutes, 1 hours and
      24 hours. The 24 hours assessment for pain as well as dyspepsia symptoms is achieved through
      patients receiving HAS scale along with a questionnaire asking to rank dyspeptic symptoms.
      The HAS scale and dyspeptic questionnaire will be marked with patient identification number.
      A self-address envelope with postage will be given to patient with instruction return once
      completed within 24 hours of original procedure. Instruction sheets along with how to take
      dyspeptic survey will also be given.

      Statistical Methods:

      Data will be entered into Microsoft Excel 2017 and SPSS version 22 statistical programs.
      Analysis will include descriptive statistics, t-test, standard error, Pearson and fisher
      exact test. Statistical significance will be established with an alpha of 0.05 for all
      comparisons.

      Adverse Events:

      Risks consist of those entailed with general anesthesia and single balloon endoscopy.

      The risk of CO2 insufflation consists of respiratory depression and CO2 embolism.16

      Recording of Adverse Events:

      At each contact with the subject, the investigator will seek information on adverse events by
      specific questioning and, as appropriate, by examination. Information on all adverse events
      will be recorded immediately (e.g., signs, symptoms, abnormal diagnostic procedures). The
      clinical course of each event will be followed until resolution, stabilization, or until it
      has been determined that the study treatment or participation is not the cause.

      Reporting of Serious Adverse Events Reports of all serious adverse events (including
      follow-up information) will be submitted to the St. Elizabeth's Mercy Health IRB within five
      business days.

      Data Management and Confidentiality Patient data will be entered into electronic
      spreadsheets. The spreadsheet will be stored as separate file, protected by unique passwords.
      Only the investigators will have access to the files and their passwords. Paper records will
      be stored in hard copy in a locked filing cabinet in the investigator's office or at the
      hospital's endoscopy suit. Should any new significant findings be made during the study, the
      patient will be made privy to these findings in a timely manner.

      Provisions to Protect the Privacy Interests of Subjects Patient consent and all other
      research related activities will take place in a private exam room. Patient will also be
      receiving a copy of their informed consent.

      Funding Source:

      No funding is being sought for this study or being received.
observational model: Other
time perspective: Prospective
measure: The reduction of post operational pain
time frame: the survey will be asked at 15minutes, 30minutes, 1hour, and 24hours post op.
description: 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.
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.
arm group label: Carbon Dioxide Insufflation
description: Received CO2 insufflation during procedure
arm group label: Air Sufflation
description: Received ambient insufflation during procedure
intervention type: Other
intervention name: carbon dioxide insufflation
description: Receives CO2 insufflation
arm group label: Carbon Dioxide Insufflation
intervention type: Other
intervention name: Air insufflation
description: Receives air insufflation
arm group label: Air Sufflation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas Geisler, D.O.
role: Principal Investigator
affiliation: North Eastern Ohio Gastroenterology and Endoscopy center
facility: 
country: United States
citation: 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
citation: 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
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