Endtidal Ethanol in Sclerotherapy

November 8, 2018 updated by: University Hospital Inselspital, Berne

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3011
        • Bern University Hospital and University of Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients undergoing ethanol sclerotherapy at the university hospital Berne over the age of 18.

Description

Inclusion Criteria:

  • undergoing ethanol sclerotherapy at the university hospital Berne

Exclusion Criteria:

  • under the age of 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endtidal ethanol concentrations in mg/dl over time
Time Frame: 1 year 2 months
1 year 2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Bloodpressure in mmHg over time
Time Frame: 1 year 2 months
1 year 2 months
Bloodpressure in mmHg over injected peripheral ethanol volume
Time Frame: 1 year 2 months
1 year 2 months
Pulse rate in beats er minute over time
Time Frame: 1 year 2 months
1 year 2 months
Pulse rate in beats er minute over injected peripheral ethanol volume
Time Frame: 1 year 2 months
1 year 2 months
Endtidal ethanol concentrations in mg/dl over injected ethanol volume
Time Frame: 1 year 2 months
1 year 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2016

Primary Completion (ACTUAL)

October 1, 2018

Study Completion (ACTUAL)

October 1, 2018

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

April 12, 2016

First Posted (ESTIMATE)

April 15, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2018

Last Update Submitted That Met QC Criteria

November 8, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Endtidal ethanol

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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