Serial Usage of Combitube in Anesthesiology (Combitube)

October 20, 2023 updated by: Michael Frass

Evaluation of Serial Usage of Combitube in Anesthesiology

Retrospective evaluation of a database of ETC routine uses during general anaesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: The oesophageal-tracheal Combitube (ETC) was designed for the use in the pre-hospital setting and has proven its value both there and in difficult airway management. The ETC is a double-lumen tube and as such it enables ventilation independent of its position in either the trachea or the oesophagus. Since laryngoscopy is not necessary for positioning the ETC, it is especially favoured in pre-hospital setting, but is also used in clinical setting.

Objectives: Retrospective evaluation of a database of ETC routine uses during general anaesthesia.

Study Type

Observational

Enrollment (Actual)

745

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

  • Austria
      • Vienna, Austria, A1090
        • Med. Univ. Vienna, Dept. Internal Med. I

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 to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing general anesthesia physical status ASA class I and II

Description

Inclusion Criteria:

  • patients ASA class I and II

Exclusion Criteria:

  • patients not able to sign informed consent

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients intubated with Combitube
Patients with Combitube intubation undergoing general anesthesia with ASA class I and II
Device: Combitube
Intubation with Combitube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate
Time Frame: 3 minutes
Measurement time in seconds using a stopwatch between grasping the tube and successful intubation
3 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: 1hour
Measurement of Body mass index by calculating height and weight of each patient
1hour
method of insertion and size of the tube,
Time Frame: 1hour
insertion with different intubation devices and diameters of tubes
1hour
Intubator's qualification and experience in the use of the ETC;
Time Frame: 1 hour
years of training and experience in intubators as well as use of ETC for at least 10 times
1 hour

Collaborators and Investigators

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

Sponsor

Michael Frass

Investigators

  • Principal Investigator: Michael Frass, MD, Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 1989

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

October 1, 2015

First Submitted That Met QC Criteria

October 6, 2015

First Posted (Estimated)

October 8, 2015

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2015/10

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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