PAN-ENTERIC CAPSULE ENDOSCOPY IN PEDIATRIC CROHN'S DISEASE - THE PED-PAN STUDY: PRELIMINARY RESULTS OF A MULTICENTER TRIAL

causes less abdominal discomfort than air. An increasing number of pediatric centers now use CO2 for all endoscopic procedures. Aims: (1) To determine if using CO2 gas during endoscopy causes less abdominal discomfort and distension in children, when compared to air. (2)To determine if CO2 is as safe and as effective as air when used during both upper endoscopy and colonoscopy in children. Hypotheses: (1) CO2 is as safe and as effective as air for endoscopic insufflation. (2) CO2 causes less abdominal pain and distension when compared to air. Methods: Double blinded, prospective, randomized clinical trial. pO2, pulse, respiration rate, and end-tidal CO2 (EtCO2) were recorded each minute. The EtCO2 was sampled with a CO2-sampling nasal cannula for patients undergoing procedural sedation and via the endotracheal tube for those who were intubated. Data was entered into REDCap. Continuous data was reported as means with SD (normal distribution), Medians with IQR (Skewed distribution) and compared with t-test or Wilcoxon signed-ranks test. Categorical data was reported as percentages and proportions and compared with Chi square or Fischer exact test. A p-value <0.05 was considered statistically significant. Results: 120 patients were enrolled, of which 61 patients were randomized to the CO2 group and 59 patients to the air group. There was no difference between groups with respect to demographics and ASA status. There was similar mix of procedures between groups and no statistically significant difference between groups in anesthesia type, duration of procedure, or endoscopist-perceived ease of inflation. In contrast to some other studies, groups did not differ with respect to change in abdominal discomfort or girth from baseline to post-procedural time points. However, there was a statistically significant difference in the percent of patients with transient hypercarbia (EtCO2 > or Z 60 mmHg) during upper endoscopy done with procedural sedation (23% (CO2) vs. 4% (air) p value Z 0.008). Conclusion: This study raises a potential concern of the safety of CO2 use in children undergoing upper endoscopy. The occurrence of hypercarbia in a significant number of children may indicate inhalation of eructated CO2 or excessive absorption of CO2. Prospective studies using more accurate measures of serum pCO2 should be done to validate or refute this potential concern.