Carbon Dioxide Insufflation During ColonoscopyNCT02502136
Efficacy and Safety of Carbon Dioxide Insufflation During Endoscopy
A study testing carbon dioxide insufflation during endoscopy in people with Carbon Dioxide Insufflation During Colonoscopy, run by Chang Gung Memorial Hospital.
Trial summary
The purpose of this study is to assess the differences of safety and efficacy of carbon dioxide insufflation instead of air during sedated or unsedated endoscopy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Carbon Dioxide Insufflation During Colonoscopy
- What is being tested?
- carbon dioxide insufflation during endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 640 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Sep 2013
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- outpatients referred for panendoscopy or colonoscopy examination
Who cannot join
- pregnancy, breast feeding, severe chronic obstructive lung disease or severe heart failure, renal function impairment, inability to understand participant information, a history of abdominal surgery, or refusal to participate in this study
About this study
Official title: The Assessment of Differences in Clinical Safety and Efficacy of Carbon Dioxide Insufflation During Sedated and Conventional Endoscopy
The purpose of this study is to assess the differences of safety and efficacy of carbon dioxide insufflation instead of air during sedated or unsedated endoscopy.
Read the detailed description
Total 640 participants who are indicated to accept endoscopic examinations or procedures will be enrolled in this study. The participants will be divided into 2 groups according to the examination field, esophagogastroduodenoscopy group (320 participants) and colonoscope group (320 participants). The participants in each group will be divided into sedated endoscope subgroup and sedated and unsedated endoscope subgroup (each subgroup is inclusive of 160 participants). Carbon dioxide (CO2) or room air will be used randomly to insufflate the bowel lumen during the procedure in each subgroup.
- Being tested
- carbon dioxide insufflation during endoscopy, Room air insufflation during endoscopy (Placebo)
- Keywords
- CO2 insufflation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbon dioxide insufflation during endoscopyProcedure or surgery
Efficacy and safety study of carbon dioxide insufflation instead of air during sedated endoscopy
Room air insufflation during endoscopy (Placebo)Procedure or surgery
Efficacy and safety study of carbon dioxide insufflation instead of air during sedated endoscopy
| Study group | Role | What they receive |
|---|---|---|
| CO2 in sedated colonoscopy | Experimental | Carbon dioxide insufflation during colonoscopy with sedation Receives: Procedure: carbon dioxide insufflation during endoscopy |
| Air in sedated colonoscopy | Placebo comparator | Room air insufflation during colonoscopy with sedation Receives: Procedure: Room air insufflation during endoscopy (Placebo) |
| CO2 in mild sedated colonoscopy | Experimental | Carbon dioxide insufflation during colonoscopy with mild sedation Receives: Procedure: carbon dioxide insufflation during endoscopy |
| Air in deep sedated colonoscopy | Placebo comparator | Room air insufflation during colonoscopy with deep sedation Receives: Procedure: Room air insufflation during endoscopy (Placebo) |
| CO2 in sedated panendoscopy | Experimental | Carbon dioxide insufflation during panendoscopy with sedation Receives: Procedure: carbon dioxide insufflation during endoscopy |
| Air in sedated panendoscopy | Placebo comparator | Room air insufflation during panendoscopy with sedation Receives: Procedure: Room air insufflation during endoscopy (Placebo) |
| CO2 in mild sedated panendoscopy | Experimental | Carbon dioxide insufflation during panendoscopy with mild sedation Receives: Procedure: carbon dioxide insufflation during endoscopy |
| Air in deep sedated panendoscopy | Placebo comparator | Room air insufflation during panendoscopy with deep sedation Receives: Procedure: Room air insufflation during endoscopy (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the participants' discomfort scale after endoscopy
Measured: within 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startApr 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbon Dioxide Insufflation During ColonoscopyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuo-Wei Chen, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502136
- Sponsor's protocol ID
- 99-4160A3
- Status last verified
- Apr 2015
- First submitted
- 1 Jul 2015
- Last updated
- 20 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Differences in Clinical Safety and Efficacy of Carbon Dioxide Insufflation During Sedated and Conventional Endoscopy
- ClinicalTrials.gov ID
- NCT02502136
- Acronym / sponsor ID
- 99-4160A3
- Keywords
- CO2 insufflation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 Jul 2015 (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.
The purpose of this study is to assess the differences of safety and efficacy of carbon dioxide insufflation instead of air during sedated or unsedated endoscopy.
Detailed description
Total 640 participants who are indicated to accept endoscopic examinations or procedures will be enrolled in this study. The participants will be divided into 2 groups according to the examination field, esophagogastroduodenoscopy group (320 participants) and colonoscope group (320 participants). The participants in each group will be divided into sedated endoscope subgroup and sedated and unsedated endoscope subgroup (each subgroup is inclusive of 160 participants). Carbon dioxide (CO2) or room air will be used randomly to insufflate the bowel lumen during the procedure in each subgroup.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| CO2 in sedated colonoscopy | Experimental | Procedure: carbon dioxide insufflation during endoscopyCarbon dioxide insufflation during colonoscopy with sedation |
| Air in sedated colonoscopy | Placebo comparator | Procedure: Room air insufflation during endoscopy (Placebo)Room air insufflation during colonoscopy with sedation |
| CO2 in mild sedated colonoscopy | Experimental | Procedure: carbon dioxide insufflation during endoscopyCarbon dioxide insufflation during colonoscopy with mild sedation |
| Air in deep sedated colonoscopy | Placebo comparator | Procedure: Room air insufflation during endoscopy (Placebo)Room air insufflation during colonoscopy with deep sedation |
| CO2 in sedated panendoscopy | Experimental | Procedure: carbon dioxide insufflation during endoscopyCarbon dioxide insufflation during panendoscopy with sedation |
| Air in sedated panendoscopy | Placebo comparator | Procedure: Room air insufflation during endoscopy (Placebo)Room air insufflation during panendoscopy with sedation |
| CO2 in mild sedated panendoscopy | Experimental | Procedure: carbon dioxide insufflation during endoscopyCarbon dioxide insufflation during panendoscopy with mild sedation |
| Air in deep sedated panendoscopy | Placebo comparator | Procedure: Room air insufflation during endoscopy (Placebo)Room air insufflation during panendoscopy with deep sedation |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- outpatients referred for panendoscopy or colonoscopy examination
Key exclusion criteria (1 listed)
- pregnancy, breast feeding, severe chronic obstructive lung disease or severe heart failure, renal function impairment, inability to understand participant information, a history of abdominal surgery, or refusal to participate in this study
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 |
|---|---|---|
| carbon dioxide insufflation during endoscopyEfficacy and safety study of carbon dioxide insufflation instead of air during sedated endoscopy | Procedure or surgery | CO2 in mild sedated colonoscopy, CO2 in mild sedated panendoscopy, CO2 in sedated colonoscopy, CO2 in sedated panendoscopy |
| Room air insufflation during endoscopy (Placebo)Efficacy and safety study of carbon dioxide insufflation instead of air during sedated endoscopy | Procedure or surgery | Air in deep sedated colonoscopy, Air in deep sedated panendoscopy, Air in sedated colonoscopy, Air in sedated panendoscopy |
Primary outcome
the participants' discomfort scale after endoscopy
Time frame: within 24hours
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 20 Jul 2015.
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.
Shuo-Wei Chen, MD principal investigator
Chang Gung Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A study testing carbon dioxide insufflation during endoscopy in people with Carbon Dioxide Insufflation During Colonoscopy, run by Chang Gung Memorial Hospital.
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 1 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 20 Jul 2015. 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. Some participants in this study may receive a placebo. 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?
the participants' discomfort scale after endoscopy (time frame: within 24hours). 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 20 Jul 2015.