Carbon Dioxide Versus Air Insufflation in Oesophago-Gastro-Duodenoscopy (OGD)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Norwegian Department of Health and Social Affairs
ClinicalTrials.gov Identifier:
NCT00627211
First received: February 6, 2008
Last updated: February 28, 2008
Last verified: February 2008
  Purpose

To achieve a satisfactory examination of the GI tract it needs to be distended during endoscopic procedures. After the examinations many patients complain of abdominal pain and discomfort. This pain has been substantially reduced by substituting room air with CO2 in both colonoscopies and ERCPs. The use of CO2 during colonoscopy has become routine practice at many endoscopy centers.

In our study we will test the hypothesis that abdominal pain after gastroscopies also can be reduced by substituting room air with CO2.


Condition Intervention
Pain
Procedure: Room air insufflation through the endoscopy rack
Procedure: CO2 insufflation using an Olympus CO2 insufflator

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Diagnostic
Official Title: A Double-Blinded, Randomized Trial Comparing Carbondioxide(CO2)and Air Insufflation in Oesophago-Gastro-Duodenoscopy (OGD)

Resource links provided by NLM:


Further study details as provided by Norwegian Department of Health and Social Affairs:

Primary Outcome Measures:
  • Pain after OGD [ Time Frame: 0-48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain during OGD [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2008
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Room air Procedure: Room air insufflation through the endoscopy rack
CO2 will be insufflated during oesophagogastroduodenoscopy in the intervention group, the control group will be examined with room air.
Active Comparator: CO2 Procedure: Room air insufflation through the endoscopy rack
CO2 will be insufflated during oesophagogastroduodenoscopy in the intervention group, the control group will be examined with room air.
Procedure: CO2 insufflation using an Olympus CO2 insufflator
From the CO2 rack through the endoscopy rack CO2 will be insufflated to visualize the mucosa during oesophagogastroduodenoscopy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for OGD at the outpatient clinic of Telemark Hospital

Exclusion Criteria:

  • Age <18
  • Inability to give an informed concent
  • Unsatisfactory norwegian language skills
  • Patients not willing to participate
  • COPD with dyspnoea NYHA 3-4
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Geir Hoff MD PhD, Southern and Eastern Norway Health Authority board
ClinicalTrials.gov Identifier: NCT00627211     History of Changes
Other Study ID Numbers: STHF Gastro BS1
Study First Received: February 6, 2008
Last Updated: February 28, 2008
Health Authority: Norway: Directorate of Health

Keywords provided by Norwegian Department of Health and Social Affairs:
quality assessment
pain reduction
gastroscopy
carbondioxide insufflation
Patient satisfaction

ClinicalTrials.gov processed this record on September 22, 2014