ColonoscopyNCT01060709
Transcutaneous Measurement of Carbon Dioxide Versus Current Sedation Practices in Sedated Patients
An observational study of Colonoscopy, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Does transcutaneous carbon dioxide partial pressure (TcCO2) monitoring detect hypoventilation prior to current sedation monitoring practices in order to prevent hypoxemia in sedated patients undergoing colonoscopies? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy
- How many people
- 250 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2009to Sep 2010
- Phase
- Observational
- 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
Study population: patients undergoing elective colonoscopy and requiring sedation
Who may be able to join
- Patients requiring sedation for colonoscopy
Who cannot join
- Patient refusal
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Groningen
Groningen, Provincie Groningen, 9713EZ
About this study
Official title: Does Transcutaneous Carbon Dioxide Partial Pressure (TcCO2) Monitoring Detect Hypoventilation Prior to Current Sedation Monitoring Practices?
Does transcutaneous carbon dioxide partial pressure (TcCO2) monitoring detect hypoventilation prior to current sedation monitoring practices in order to prevent hypoxemia in sedated patients undergoing colonoscopies?
- Conditions
- Colonoscopy
- Keywords
- Carbon dioxide, TcC02, Hypoventilation, endoscopic, elective colonoscopy and requiring sedation
- Medical subject headings
- Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| elective colonoscopy and requiring sedation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does transcutaneous carbon dioxide partial pressure (TcCO2) monitoring detect hypoventilation prior to current sedation monitoring practices in order to prevent hypoxemia in sedated patients undergoing colonoscopies?
Measured: one year
Secondary outcomes (1)
To verify if there is an association with the following variables: age, gender, weight, length, ASA-classification, sedation depth (BIS), co-morbidity, diagnostic or therapeutic colonoscopy.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startDec 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Investigators
- J K Oosterhuis, Drs, Study director, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060709
- Sponsor's protocol ID
- TcCo2-001
- Status last verified
- Nov 2009
- First submitted
- 1 Feb 2010
- Last updated
- 26 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Transcutaneous Carbon Dioxide Partial Pressure (TcCO2) Monitoring Detect Hypoventilation Prior to Current Sedation Monitoring Practices?
- ClinicalTrials.gov ID
- NCT01060709
- Acronym / sponsor ID
- TcCo2-001
- Conditions
- Colonoscopy
- Keywords
- Carbon dioxide, TcC02, Hypoventilation, endoscopic, elective colonoscopy and requiring sedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 2 Feb 2010 (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.
Does transcutaneous carbon dioxide partial pressure (TcCO2) monitoring detect hypoventilation prior to current sedation monitoring practices in order to prevent hypoxemia in sedated patients undergoing colonoscopies?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| elective colonoscopy and requiring sedation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing elective colonoscopy and requiring sedation
Key inclusion criteria (1 listed)
- Patients requiring sedation for colonoscopy
Key exclusion criteria (1 listed)
- Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Does transcutaneous carbon dioxide partial pressure (TcCO2) monitoring detect hypoventilation prior to current sedation monitoring practices in order to prevent hypoxemia in sedated patients undergoing colonoscopies?
Time frame: one year
1 secondary outcome
To verify if there is an association with the following variables: age, gender, weight, length, ASA-classification, sedation depth (BIS), co-morbidity, diagnostic or therapeutic colonoscopy.
Time frame: one year
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 26 Oct 2010.
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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.
J K Oosterhuis, Drs study director
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonoscopy, run by University Medical Center Groningen at 1 site in Netherlands.
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 26 Oct 2010. 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 Netherlands. 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. 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?
Does transcutaneous carbon dioxide partial pressure (TcCO2) monitoring detect hypoventilation prior to current sedation monitoring practices in order to prevent hypoxemia in sedated patients undergoing colonoscopies? (time frame: one year). 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 26 Oct 2010.