Carbon Dioxide Insufflation Versus Conventional Air Insufflation

NCT02790359 | Completed

• 1 other identifier: 728555
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The safety and effectiveness of esophagogastroduodenoscopy and colonoscopy in the detection of gastrointestinal-tract pathology in children has been established during the last three decades. Insufflation of the intestinal tract, usually with room air, is necessary to improve visualization during the procedure; however, air in the bowels can also result in abdominal distension and increased pain. This potential discomfort associated with upper endoscopy and colonoscopy may be an important barrier to patients undergoing this procedure. Insufflation with carbon dioxide is another method used in endoscopic procedures for distention of the lumen and is currently used at the Children's Hospital of Wisconsin based on provider preference. The aim of this study is to perform a randomized controlled trial comparing insufflation with room air to carbon dioxide in patients undergoing routine upper endoscopy and colonoscopy. The investigators primary outcome is measurement of patient comfort level as measured by pain scores during recovery. The investigators hypothesize that carbon dioxide insufflation during endoscopy and colonoscopy improves patient comfort level as compared with insufflation with room air. Secondary outcome measures include changes in end tidal carbon dioxide, time to discharge, duration of colonoscopy and cecal intubation rate, changes in abdominal girth, rescue pain medications used during recovery and post-procedure events. This is a prospective randomized single-blinded study. The investigators will recruit consecutive patients, between the ages of 8 and 21 years, scheduled for elective outpatient upper endoscopy and colonoscopy at children's hospital of Wisconsin from March 2015 until we reach target population numbers. The investigators will exclude all inpatients, non-English speaking patients, children under 8 years of age, patients undergoing colonic manometry studies, and patients with hemodynamic instability, gastrointestinal bleeding, acute abdomen, previous colectomy, oxygen-dependent pulmonary disease and obstructive sleep apnea requiring the use of continuous positive airway pressure device. On the basis of a computer-generated randomization scheme in a 1:1 ratio, patients will be assigned to receive room air or carbon dioxide for insufflation during colonoscopy. Power calculation was done and determined that we will need to enroll 100 patients in each arm of the study. Informed consent will be obtained from all patients by the endoscopist or gastrointestinal fellow.

Conditions

Abdominal Pain

Keywords

Carbon dioxide; Air; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Abdominal pain based on visual analog scale

  Participants abdominal pain score will be assessed based on visual analog scale

  72 hours

Study Arms (2)

Patient group 1

ACTIVE COMPARATOR

Air

Other: Air

Patient group 2

ACTIVE COMPARATOR

Carbon dioxide

Other: Carbon dioxide

Interventions

Air OTHER

Group of patients who would receive air insufflation

Patient group 1

Carbon dioxide OTHER

Group of patients who would receive carbon dioxide insufflation

Patient group 2

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ages of 8 and 21 years
• elective outpatient upper endoscopy and colonoscopy

You may not qualify if:

• inpatients
• non-English speaking patients
• children under 8 years of age
• patients undergoing colonic manometry studies
• patients with hemodynamic instability
• GI bleeding
• acute abdomen
• previous colectomy
• oxygen-dependent pulmonary disease and obstructive sleep apnea

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Childrens Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Location

MeSH Terms

Conditions

Abdominal Pain

Interventions

Air; Carbon Dioxide

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health; Carbon Compounds, Inorganic; Inorganic Chemicals; Gases; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: June 3, 2016
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: December 13, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)