- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00627211
Carbon Dioxide Versus Air Insufflation in Oesophago-gastro-duodenoscopy (OGD)
A Double-blinded, Randomized Trial Comparing Carbondioxide(CO2)and Air Insufflation in Oesophago-gastro-duodenoscopy (OGD)
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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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