Ethanol Concentration Clinical Trial
Official title:
Endtidal Ethanol in Sclerotherapy
| NCT number | NCT02740855 |
| Other study ID # | Endtidal ethanol |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 2016 |
| Est. completion date | October 2018 |
| Verified date | November 2018 |
| Source | University Hospital Inselspital, Berne |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 70 |
| Est. completion date | October 2018 |
| Est. primary completion date | October 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - undergoing ethanol sclerotherapy at the university hospital Berne Exclusion Criteria: - under the age of 18 |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Bern University Hospital and University of Bern | Bern |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Inselspital, Berne |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Endtidal ethanol concentrations in mg/dl over time | 1 year 2 months | ||
| Secondary | Bloodpressure in mmHg over time | 1 year 2 months | ||
| Secondary | Bloodpressure in mmHg over injected peripheral ethanol volume | 1 year 2 months | ||
| Secondary | Pulse rate in beats er minute over time | 1 year 2 months | ||
| Secondary | Pulse rate in beats er minute over injected peripheral ethanol volume | 1 year 2 months | ||
| Secondary | Endtidal ethanol concentrations in mg/dl over injected ethanol volume | 1 year 2 months |