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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00627211
First Posted: February 29, 2008
Last Update Posted: September 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Geir Hoff, Norwegian Department of Health and Social Affairs
  Purpose
Comparison on the effect on patient pain and discomfort by using CO2 instead of air for insufflation during gastroscopy.

Condition Intervention
Pain Procedure: CO2 insufflation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
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 Geir Hoff, Norwegian Department of Health and Social Affairs:

Primary Outcome Measures:
  • Pain after OGD [ Time Frame: 0-48 hours ]

Secondary Outcome Measures:
  • Pain during OGD [ Time Frame: 24 hours ]

Enrollment: 107
Study Start Date: February 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
No Contacts or Locations Provided
  More Information

Responsible Party: Geir Hoff, Professor, Norwegian Department of Health and Social Affairs
ClinicalTrials.gov Identifier: NCT00627211     History of Changes
Other Study ID Numbers: STHF Gastro BS1
First Submitted: February 6, 2008
First Posted: February 29, 2008
Last Update Posted: September 15, 2017
Last Verified: September 2017

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