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

Sponsor:	Norwegian Department of Health and Social Affairs
Information provided by:	Norwegian Department of Health and Social Affairs
ClinicalTrials.gov Identifier:	NCT00627211

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:

MedlinePlus related topics: Endoscopy

Drug Information available for: Carbon dioxide

U.S. FDA Resources

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

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 for Health and Social Affairs

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 February 09, 2012