Safety and Efficacy of CO2 for Endoscopy
Condition: Endoscopy; Insufflation
Study type: Interventional
Phase: Phase 4

Summary: 
      Hypothesis:

      Carbon dioxide gas use for endoscopic insufflation is safe and results in less abdominal
      distension and discomfort; it is equally effective as air in pediatric patients undergoing
      endoscopic procedures.

      Aim 1:

      Determine the occurrence and severity of abdominal discomfort and distension associated with
      endoscopic procedures at baseline, upon awakening from anesthesia, at discharge and at 4
      hours after discharge in carbon dioxide group when compared to the air group.

      Aim 2:

      Determine if the expertise level of the endoscopist contributes to abdominal discomfort and
      distension following endoscopy, and whether this differs in the carbon dioxide group versus
      air group.

      Aim 3:

      Determine if carbon dioxide is as effective as air for insufflation.
    

Detailed description: 
      STUDY DESIGN: A Prospective, Randomized, Double-Blinded, Controlled Trial We intend to enroll
      250 patients aged between 6 months and 21 years in a randomized, double-blind study comparing
      the use of air (our current routine) vs. carbon dioxide (CO2) for insufflation (inflation) of
      the gut during endoscopy. The primary endpoint will be abdominal girth and abdominal
      pain/discomfort after undergoing the endoscopy. Secondary endpoints will be indirect measures
      of CO2 absorption (respiratory rate and end-tidal CO2)throughout the procedure, determination
      whether the endoscopist's training level influences the primary endpoint,and determination if
      CO2 and air are equally effective for adequate intestinal visualization . Similar studies in
      adults have demonstrated safety and efficacy of CO2 in minimizing bloating and abdominal pain
      following endoscopy and show no difference in efficacy of insufflation. However, studies done
      to date in children have not been comprehensive in data gathering and analysis. We now have
      the capability to routinely use CO2 for insufflation in our new Stead Family Children's
      Hospital procedure unit, and wish to take this opportunity to fully document both efficacy
      and safety of CO2 insufflation in children undergoing our most common endoscopic procedures,
      including esophagogastroduodenoscopy (EGD, upper endoscopy,) colonoscopy, or combined upper
      endoscopy and colonoscopy. All patients in the study will be sedated by the anesthesia team
      using propofol as the primary agent. We will exclude patients who are judged to be at risk of
      respiratory compromise.

      Informed consent will be obtained as always for the procedure itself; additional consent and/
      assent (when appropriate) will be obtained for study participation. For patients or parents
      who opt out of the study; air will be used, as per our current routine, for insufflation.
      Those willing to participate in the study will be randomly assigned to either carbon dioxide
      or air for insufflation during their endoscopic procedure. Both the endoscopist and patient
      will be blinded to arm of study.

      DATA COLLECTION: At baseline, routine vital signs (HR, BP, RR, oxygen saturation), end tidal
      CO2, and pain assessment (see below) will be documented. Abdominal girth, measured at the
      umbilicus, will be documented at baseline as well. The expertise level of the primary
      endoscopist will be noted; fellow (1st, 2nd, or 3rd year) or faculty will be recorded. A
      faculty gastroenterologist will be present for the entire procedure.

      During the endoscopic procedure, again as per our usual routine, end-tidal CO2 will be
      continuously monitored and recorded in Epic by the anesthesia team. Other parameters that
      will be monitored and recorded continuously will include, HR, BP respiratory rate, and oxygen
      saturation. Based on published studies, we do not anticipate any evidence of detectable CO2
      absorption during the procedure, but will be prepared to unblind the study and switch to air
      insufflation if any concern arises during the procedure. The duration and type of procedure
      will be noted for all patients.

      At the end of the procedure, Heart rate (HR) , Blood pressure (BP), respiratory rate (RR),
      oxygen saturation, end tidal CO2, abdominal girth, and pain assessment will be documented
      again. "Breath to breath" analysis of the end tidal CO2 monitor tracing will be performed
      later, using recorded data, study by Dr. Timothy Starner (Pediatric pulmonologist). This will
      enable us to determine if there had been any evidence of an increased respiratory rate
      associated with increased CO2 absorption.

      We will use the verbal scale : face, legs, activity, cry, consolability (FLACC) scale to
      assess pain upon arrival to recovery area. After awakening, abdominal discomfort will be
      assessed for children who are able to do so, and the assessment will be repeated at discharge
      from the facility. FLACC will be used for all children with appropriate developmental status,
      age 5 years and older for normal children. After discharge, the parents will complete an
      additional brief pain assessment at home at 4 hours after discharge. For those who had an
      abdominal girth increase of at least 10% from baseline, abdominal girth will be re-measured
      at home, at 4 hours after discharge.

      We will use the non-verbal FLACC scale for children unable to verbally report pain using the
      visual scale.

      Parents will report pain and abdominal girth data done at home by returning a pre-stamped
      postcard. Those who do not communicate this information will be called by a member of the
      research team for this information after five working days.

      We hypothesize, based on adult and few pediatric studies, that post-procedure abdominal
      discomfort will be significantly decreased in the CO2 group, and that CO2 will be shown to be
      safe and effective for endoscopic insufflation.

      Efficacy of insufflation will be assessed by the endoscopist immediately after the procedure
      using a 5-point Likert scale.
    

Intervention name(s): Carbon dioxide (CO2) gas insufflation; Air insufflation
Intervention type(s): Drug; Drug
Intervention description(s): CO2 gas use for insufflation during endoscopy instead of air insufflation; Air insufflation is the standard of practice (used in the control arm)
Other intervention name(s): CO2; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blinded, placebo controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other