Endtidal Ethanol in Sclerotherapy

Completed

• Conditions: Ethanol Concentration

• Registration Number: NCT02740855
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-15
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-08
• Last Update Posted: 2018-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• undergoing ethanol sclerotherapy at the university hospital Berne

Exclusion Criteria

• under the age of 18

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endtidal ethanol concentrations in mg/dl over time	1 year 2 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bern University Hospital and University of Bern; 🇨🇭 Bern, Switzerland