NCT00627211

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Feb 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2008

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 29, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

September 15, 2017

Status Verified

September 1, 2017

Enrollment Period

1 year

First QC Date

February 6, 2008

Last Update Submit

September 14, 2017

Conditions

Pain

Keywords

quality assessmentpain reductiongastroscopycarbondioxide insufflationPatient satisfaction

Outcome Measures

Primary Outcomes (1)

  • Pain after OGD

    0-48 hours

Secondary Outcomes (1)

  • Pain during OGD

    24 hours

Study Arms (2)

Room air insufflation

NO INTERVENTION

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.

CO2 insufflation

EXPERIMENTAL

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

Interventions

CO2 insufflationPROCEDURE

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

CO2 insufflation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for OGD at the outpatient clinic of Telemark Hospital

You may not qualify if:

  • Age \<18
  • Inability to give an informed concent
  • Unsatisfactory norwegian language skills
  • Patients not willing to participate
  • COPD with dyspnoea NYHA 3-4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PainPatient Satisfaction

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 6, 2008

First Posted

February 29, 2008

Study Start

February 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

September 15, 2017

Record last verified: 2017-09