Comparison Air Versus Carbon Dioxide Insufflation in Single Balloon Anterograde Enteroscopy

February 13, 2019 updated by: North Eastern Ohio Gastroenterology and Endoscopy center
Observation study comparing patient symptoms of bloating, pain, and nausea between CO2 insufflation vs. O2 insufflation in anterograde balloon enteroscopy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Warren, Ohio, United States, 44484
        • St. Joesph Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
the survey will be asked at 15minutes, 30minutes, 1hour, and 24hours post op.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Eastern Ohio Gastroenterology and Endoscopy center

Collaborators

Mercy Health Ohio

Investigators

  • Principal Investigator: Thomas Geisler, D.O., North Eastern Ohio Gastroenterology and Endoscopy center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

January 11, 2019

First Submitted That Met QC Criteria

January 17, 2019

First Posted (Actual)

January 22, 2019

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 13, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • NEOGastro

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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