Carbon Dioxide InsufflationNCT01807312
The Application of CO2 Insufflations in Routine Colonoscopy Examination for Duration in Toilet After Examination Compared With Air Insufflations
A study testing Endoscopic CO2 regulation unit and accessories in people with Carbon Dioxide Insufflation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
It has been reported that carbon dioxide (CO2) insufflation can reduce patient pain and abdominal discomfort during and after colonoscopy. Its safety and efficacy during colonoscopy even under sedation has been already assessed in some earlier trials. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Carbon Dioxide Insufflation
- What is being tested?
- Endoscopic CO2 regulation unit and accessories
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2013to Aug 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged between 20 and 80 years who receive Screening colonoscopy
Who cannot join
- Subjects who have chronic lung diseases or cardiovascular diseases
Trial locations and contacts
1 site in 1 country.
About this study
It has been reported that carbon dioxide (CO2) insufflation can reduce patient pain and abdominal discomfort during and after colonoscopy. Its safety and efficacy during colonoscopy even under sedation has been already assessed in some earlier trials. Air insufflation is still the standard method, however, due a lack of suitable replacement of equipment or technical improvement in colonoscopy.
The investigators use radio frequency identification (RFID) technology to record the number of times and duration in the toilet of the patient after colonoscopy examination. These data may be proxies for discomfort. With application of CO2 insufflation, the times and duration in the toilet after examination will decrease as well as patient's discomfort after procedure, and further improvement of patient compliance can be anticipated.
Read the detailed description
It has been reported that carbon dioxide (CO2) insufflation can reduce patient pain and abdominal discomfort during and after colonoscopy. Its safety and efficacy during colonoscopy even under sedation has been already assessed in some earlier trials. Air insufflation is still the standard method, however, due a lack of suitable replacement of equipment or technical improvement in colonoscopy.
In laparoscopic surgery, CO2 insufflation is widely applied and safely used for patients under general anesthesia. CO2 insufflation is also applied in CT colonography for reduction of discomfort during or after procedure. During endoscopic procedure for colorectal neoplasia resection, however, long procedural time may increase not only the degree of discomfort during and after the procedure but also the risk of perforation. In addition to laparoscopic surgery, CO2 insufflation has also been applied to other endoscopic procedures. Saito et al reported the application of CO2 insufflation in endoscopic submucosal dissection (ESD) of colorectal neoplasia in a prospective study in which their average procedural time using CO2 insufflation was 90 minutes under conscious sedation with average of 5.6 mg of midazolam. When compared with control group using room air, statistically negligible difference of pCO2 was observed with significant difference in abdominal discomfort. Screening colonoscopy, which can be completed within 15 minutes if no lesion has been detected, requires high screenee satisfaction so as to improve patient compliance. In the setting of colonoscopy after positive FOBT, the attendance rate for secondary colonoscopy was around 60 to 70 % according to the data demonstrated in previous RCT and population-based studies.
Recently, radio frequency identification (RFID) technology, a 'wireless automatic identification and data capture (AIDC) technology has emerged as a multidimensional innovation that can accelerate the transformation of healthcare processes. The effective adoption and use of RFID technology is expected to transform intra- and inter-organisational business processes, thus allowing intra- and inter-firms business process innovation, real-time data collection and sharing at the supply chain level, business analytics and improved decision making. In the specific context of the healthcare sector, RFID technology offers a better means for patient identification, tracking, and tracing.We use radio frequency identification (RFID) technology to record the number of times and duration in the toilet of the patient after colonoscopy examination. These data may be proxies for discomfort. With application of CO2 insufflation, the times and duration in the toilet after examination will decrease as well as patient's discomfort after procedure, and further improvement of patient compliance can be anticipated.
- Conditions
- Carbon Dioxide Insufflation
- Being tested
- Endoscopic CO2 regulation unit and accessories, Placebo
- Keywords
- colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic CO2 regulation unit and accessoriesDevice
Olympus UCR Endoscopic CO2 Regulation Unit
PlaceboDevice
| Study group | Role | What they receive |
|---|---|---|
| CO2 insufflation | Experimental | CO2 insufflations was applicated in routine colonoscopy examination with Endoscopic CO2 regulation unit and accessories Receives: Device: Endoscopic CO2 regulation unit and accessories |
| Air insufflation | Placebo comparator | Air insufflations is applicated in Routine Colonoscopy Examination Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of times and duration in the toilet of the patient after colonoscopy examination
Measured: Two hours after examination
Secondary outcomes (1)
the point of pain scoring system after colonoscopy examination
Measured: Two hours after examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbon Dioxide InsufflationStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Han-Mo Chiu, PhD, Principal investigator, Department of Internal Medicine, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807312
- Sponsor's protocol ID
- 201211070RIC
- Status last verified
- Aug 2013
- First submitted
- 6 Mar 2013
- Last updated
- 27 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of CO2 Insufflations in Routine Colonoscopy Examination for Duration in Toilet After Examination Compared With Air Insufflations
- ClinicalTrials.gov ID
- NCT01807312
- Acronym / sponsor ID
- 201211070RIC
- Conditions
- Carbon Dioxide Insufflation
- Keywords
- colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 8 Mar 2013 (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.
It has been reported that carbon dioxide (CO2) insufflation can reduce patient pain and abdominal discomfort during and after colonoscopy. Its safety and efficacy during colonoscopy even under sedation has been already assessed in some earlier trials. Air insufflation is still the standard method, however, due a lack of suitable replacement of equipment or technical improvement in colonoscopy.
The investigators use radio frequency identification (RFID) technology to record the number of times and duration in the toilet of the patient after colonoscopy examination. These data may be proxies for discomfort. With application of CO2 insufflation, the times and duration in the toilet after examination will decrease as well as patient's discomfort after procedure, and further improvement of patient compliance can be anticipated.
Detailed description
It has been reported that carbon dioxide (CO2) insufflation can reduce patient pain and abdominal discomfort during and after colonoscopy. Its safety and efficacy during colonoscopy even under sedation has been already assessed in some earlier trials. Air insufflation is still the standard method, however, due a lack of suitable replacement of equipment or technical improvement in colonoscopy.
In laparoscopic surgery, CO2 insufflation is widely applied and safely used for patients under general anesthesia. CO2 insufflation is also applied in CT colonography for reduction of discomfort during or after procedure. During endoscopic procedure for colorectal neoplasia resection, however, long procedural time may increase not only the degree of discomfort during and after the procedure but also the risk of perforation. In addition to laparoscopic surgery, CO2 insufflation has also been applied to other endoscopic procedures. Saito et al reported the application of CO2 insufflation in endoscopic submucosal dissection (ESD) of colorectal neoplasia in a prospective study in which their average procedural time using CO2 insufflation was 90 minutes under conscious sedation with average of 5.6 mg of midazolam. When compared with control group using room air, statistically negligible difference of pCO2 was observed with significant difference in abdominal discomfort. Screening colonoscopy, which can be completed within 15 minutes if no lesion has been detected, requires high screenee satisfaction so as to improve patient compliance. In the setting of colonoscopy after positive FOBT, the attendance rate for secondary colonoscopy was around 60 to 70 % according to the data demonstrated in previous RCT and population-based studies.
Recently, radio frequency identification (RFID) technology, a 'wireless automatic identification and data capture (AIDC) technology has emerged as a multidimensional innovation that can accelerate the transformation of healthcare processes. The effective adoption and use of RFID technology is expected to transform intra- and inter-organisational business processes, thus allowing intra- and inter-firms business process innovation, real-time data collection and sharing at the supply chain level, business analytics and improved decision making. In the specific context of the healthcare sector, RFID technology offers a better means for patient identification, tracking, and tracing.We use radio frequency identification (RFID) technology to record the number of times and duration in the toilet of the patient after colonoscopy examination. These data may be proxies for discomfort. With application of CO2 insufflation, the times and duration in the toilet after examination will decrease as well as patient's discomfort after procedure, and further improvement of patient compliance can be anticipated.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO2 insufflation | Experimental | Device: Endoscopic CO2 regulation unit and accessoriesCO2 insufflations was applicated in routine colonoscopy examination with Endoscopic CO2 regulation unit and accessories |
| Air insufflation | Placebo comparator | Device: PlaceboAir insufflations is applicated in Routine Colonoscopy Examination |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects aged between 20 and 80 years who receive Screening colonoscopy
Key exclusion criteria (1 listed)
- Subjects who have chronic lung diseases or cardiovascular diseases
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 |
|---|---|---|
| Endoscopic CO2 regulation unit and accessoriesOlympus UCR Endoscopic CO2 Regulation Unit | Device | CO2 insufflation |
| Placebo | Device | Air insufflation |
Primary outcome
The number of times and duration in the toilet of the patient after colonoscopy examination
Time frame: Two hours after examination
1 secondary outcome
the point of pain scoring system after colonoscopy examination
Time frame: Two hours after examination
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 27 Aug 2013.
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.
Han-Mo Chiu, PhD principal investigator
Department of Internal Medicine, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic CO2 regulation unit and accessories in people with Carbon Dioxide Insufflation, run by National Taiwan University Hospital at 1 site in Taiwan.
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 27 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 number of times and duration in the toilet of the patient after colonoscopy examination (time frame: Two hours after examination). 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 27 Aug 2013; AzTrials last refreshed its copy on 7 Nov 2026.