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

NCT ID: NCT00627211

Last Updated: 2017-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-02-28

Brief Summary

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

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

CO2 insufflation

Intervention Type: PROCEDURE

From the CO2 rack through the endoscopy rack CO2 will be insufflated to visualize the mucosa during oesophagogastroduodenoscopy.

Interventions

CO2 insufflation

From the CO2 rack through the endoscopy rack CO2 will be insufflated to visualize the mucosa during oesophagogastroduodenoscopy.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian Department of Health and Social Affairs

OTHER_GOV

Sponsor Role: lead

Responsible Party

Geir Hoff

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

STHF Gastro BS1

Identifier Type: -

Identifier Source: org_study_id