PainNCT00627211
Carbon Dioxide Versus Air Insufflation in Oesophago-gastro-duodenoscopy (OGD)
A study testing CO2 insufflation in people with Pain, run by Norwegian Department of Health and Social Affairs.
Trial summary
Comparison on the effect on patient pain and discomfort by using CO2 instead of air for insufflation during gastroscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- CO2 insufflation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Feb 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for OGD at the outpatient clinic of Telemark Hospital
Who cannot join
- Age <18
- Inability to give an informed concent
- Unsatisfactory norwegian language skills
- Patients not willing to participate
- COPD with dyspnoea NYHA 3-4
About this study
Official title: A Double-blinded, Randomized Trial Comparing Carbondioxide(CO2)and Air Insufflation in Oesophago-gastro-duodenoscopy (OGD)
Comparison on the effect on patient pain and discomfort by using CO2 instead of air for insufflation during gastroscopy.
Read the 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
- Being tested
- CO2 insufflation
- Keywords
- quality assessment, pain reduction, gastroscopy, carbondioxide insufflation, Patient satisfaction
- Medical subject headings
- Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 insufflationProcedure or surgery
From the CO2 rack through the endoscopy rack CO2 will be insufflated to visualize the mucosa during oesophagogastroduodenoscopy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: CO2 insufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain after OGD
Measured: 0-48 hours
Secondary outcomes (1)
Pain during OGD
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Department of Health and Social Affairs
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Geir Hoff, Norwegian Department of Health and Social Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627211
- Sponsor's protocol ID
- STHF Gastro BS1
- Status last verified
- Sep 2017
- First submitted
- 6 Feb 2008
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded, Randomized Trial Comparing Carbondioxide(CO2)and Air Insufflation in Oesophago-gastro-duodenoscopy (OGD)
- ClinicalTrials.gov ID
- NCT00627211
- Acronym / sponsor ID
- STHF Gastro BS1
- Conditions
- Pain
- Keywords
- quality assessment, pain reduction, gastroscopy, carbondioxide insufflation, Patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Norwegian Department of Health and Social AffairsOther government
- Study start
- Feb 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 29 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: CO2 insufflationCO2 used for insufflation during gastroscopy to expand the lumen for inspection of the mucosal lining. This is not standard procedure and therefore experimental intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for OGD at the outpatient clinic of Telemark Hospital
Key exclusion criteria (5 listed)
- Age <18
- Inability to give an informed concent
- Unsatisfactory norwegian language skills
- Patients not willing to participate
- COPD with dyspnoea NYHA 3-4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2 insufflationFrom the CO2 rack through the endoscopy rack CO2 will be insufflated to visualize the mucosa during oesophagogastroduodenoscopy. | Procedure or surgery | CO2 insufflation |
Primary outcome
Pain after OGD
Time frame: 0-48 hours
1 secondary outcome
Pain during OGD
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 insufflation in people with Pain, run by Norwegian Department of Health and Social Affairs.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain after OGD (time frame: 0-48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2017.