Carbon Dioxide Versus Air Insufflation in Oesophago-gastro-duodenoscopy (OGD)

September 14, 2017 updated by: Geir Hoff, Norwegian Department of Health and Social Affairs

A Double-blinded, Randomized Trial Comparing Carbondioxide(CO2)and Air Insufflation in Oesophago-gastro-duodenoscopy (OGD)

Comparison on the effect on patient pain and discomfort by using CO2 instead of air for insufflation during gastroscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Room air insufflation
Air used for insufflation during gastroscopy to expand the lumen for inspection of the mucosal lining. This is current standard procedure, i.e. no experimental intervention.
Experimental: CO2 insufflation
CO2 used for insufflation during gastroscopy to expand the lumen for inspection of the mucosal lining. This is not standard procedure and therefore experimental intervention.
Procedure: CO2 insufflation
From the CO2 rack through the endoscopy rack CO2 will be insufflated to visualize the mucosa during oesophagogastroduodenoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain after OGD
Time Frame: 0-48 hours
0-48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain during OGD
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian Department of Health and Social Affairs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

February 6, 2008

First Submitted That Met QC Criteria

February 28, 2008

First Posted (Estimate)

February 29, 2008

Study Record Updates

Last Update Posted (Actual)

September 15, 2017

Last Update Submitted That Met QC Criteria

September 14, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STHF Gastro BS1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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