Safety and Efficacy of CO2 for Endoscopy
Condition: Endoscopy; Insufflation
Intervention: Carbon dioxide (CO2) gas insufflation; Air insufflation
Intervention description: CO2 gas use for insufflation during endoscopy instead of air insufflation; Air insufflation is the standard of practice (used in the control arm)
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blinded, placebo controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Randomization will be done 1:1, double blinded. - Procedure nurse will randomly choose an envelope from a box; the envelope contains a card listing either "CO2" or "Air". The envelopes will be unmarked and will be prepared with an equal number of cards for each arm. The procedure nurse then turns on either CO2 or air insufflation according to the card in the envelope. The air/CO2 controls will be kept covered to preserve blinding of the endoscopist. She will also record the patient's arm allocation in a logbook, which will be kept in a locked cabinet.
These events will precede entry of the patient and endoscopist into the procedure room.
Therefore, all study participants are blinded and allocation is also blinded also.
Enrollment: 180.0
Sex: All
Minimum age: 6 Months
Maximum age: 21 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pediatric gastroenterology patients aged 6 months through 21 years undergoing
             endoscopic procedures in the Stead Family Children's Hospital (SFCH) Lower Level 2
             procedure room or the operating room in the SFCH who willingly consent/ascent to the
             study. These procedures will range from Esophagogastroduodenoscopy, Colonoscopy, and
             those having both Esophagogastroduodenoscopy and Colonoscopy.

        Exclusion Criteria:

          -  Non English speaking families who require the services of a translator Children
             outside the stipulated age range of study. Children in foster care homes or wards of
             the court. Children and parents who do not willingly consent to the study Children
             with history of bronchopulmonary dysplasia or other chronic respiratory compromise.