Ethanol ConcentrationNCT02740855
Endtidal Ethanol in Sclerotherapy
An observational study of Ethanol Concentration, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
During the ethanol sclerotherapy procedure, the investigators will record doses of and time of ethanol injections and record ethanol concentrations in endtidal breath every 5 minutes. Furthermore after every ethanol injection the concentration will be measured every minute for 5 minutes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ethanol Concentration
- What is being tested?
- Alcomed 3011®
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2016to Oct 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients undergoing ethanol sclerotherapy at the university hospital Berne over the age of 18.
Who may be able to join
- undergoing ethanol sclerotherapy at the university hospital Berne
Who cannot join
- under the age of 18
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Bern University Hospital and University of Bern
Bern, 3011
About this study
During the ethanol sclerotherapy procedure, the investigators will record doses of and time of ethanol injections and record ethanol concentrations in endtidal breath every 5 minutes. Furthermore after every ethanol injection the concentration will be measured every minute for 5 minutes. To do so, the investigators will attach a breath alcohol testing device to the expiratory carbon dioxide measuring unit. Since this is the new standard of the university hospital Berne all patients undergo the same procedure. There is no study specific intervention. In this study the investigators will only document the breath alcohol levels, doses and timing of ethanol injections. All other data will be obtained from the anesthesia information system. During the two months of the study, the investigators will also record endtidal ethanol concentration after anesthesia in the postoperative care unit discharge from the unit.
The intention is to show the correlation between injected ethanol doses and measured endtidal ethanol concentration over the entire time of the intervention.
- Conditions
- Ethanol Concentration
- Being tested
- Alcomed 3011®
- Keywords
- sclerotherapy, ethanol, pulmonal hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcomed 3011®Device
Endtidal ethanol measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
Endtidal ethanol concentrations in mg/dl over time
Measured: 1 year 2 months
Secondary outcomes (5)
Bloodpressure in mmHg over time
Measured: 1 year 2 months
Bloodpressure in mmHg over injected peripheral ethanol volume
Measured: 1 year 2 months
Pulse rate in beats er minute over time
Measured: 1 year 2 months
Pulse rate in beats er minute over injected peripheral ethanol volume
Measured: 1 year 2 months
Endtidal ethanol concentrations in mg/dl over injected ethanol volume
Measured: 1 year 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ethanol ConcentrationStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740855
- Sponsor's protocol ID
- Endtidal ethanol
- Status last verified
- Nov 2018
- First submitted
- 5 Apr 2016
- Last updated
- 9 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endtidal Ethanol in Sclerotherapy
- ClinicalTrials.gov ID
- NCT02740855
- Acronym / sponsor ID
- Endtidal ethanol
- Conditions
- Ethanol Concentration
- Keywords
- sclerotherapy, ethanol, pulmonal hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 15 Apr 2016 (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.
During the ethanol sclerotherapy procedure, the investigators will record doses of and time of ethanol injections and record ethanol concentrations in endtidal breath every 5 minutes. Furthermore after every ethanol injection the concentration will be measured every minute for 5 minutes. To do so, the investigators will attach a breath alcohol testing device to the expiratory carbon dioxide measuring unit. Since this is the new standard of the university hospital Berne all patients undergo the same procedure. There is no study specific intervention. In this study the investigators will only document the breath alcohol levels, doses and timing of ethanol injections. All other data will be obtained from the anesthesia information system. During the two months of the study, the investigators will also record endtidal ethanol concentration after anesthesia in the postoperative care unit discharge from the unit.
The intention is to show the correlation between injected ethanol doses and measured endtidal ethanol concentration over the entire time of the intervention.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing ethanol sclerotherapy at the university hospital Berne over the age of 18.
Key inclusion criteria (1 listed)
- undergoing ethanol sclerotherapy at the university hospital Berne
Key exclusion criteria (1 listed)
- under the age of 18
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 |
|---|---|---|
| Alcomed 3011®Endtidal ethanol measurement | Device | – |
Primary outcome
Endtidal ethanol concentrations in mg/dl over time
Time frame: 1 year 2 months
5 secondary outcomes
Bloodpressure in mmHg over time
Time frame: 1 year 2 months
Bloodpressure in mmHg over injected peripheral ethanol volume
Time frame: 1 year 2 months
Pulse rate in beats er minute over time
Time frame: 1 year 2 months
Pulse rate in beats er minute over injected peripheral ethanol volume
Time frame: 1 year 2 months
Endtidal ethanol concentrations in mg/dl over injected ethanol volume
Time frame: 1 year 2 months
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 9 Nov 2018.
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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.
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 Ethanol Concentration, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 9 Nov 2018. 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 Switzerland. 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?
Endtidal ethanol concentrations in mg/dl over time (time frame: 1 year 2 months). 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 9 Nov 2018.