Safety and Efficacy of CO2 for Endoscopy

Age Range:Any - 21
Start Date:November 27, 2017
End Date:January 2019
Contact:Chinenye R Dike, MD
Phone:319 356 2950

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The Safety and Efficacy of Carbon Dioxide for Insufflation During Endoscopy in Pediatric Patients


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.

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.

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.
We found this trial at
101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Phone: 319-356-2950
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