Electric Impedance Tomography Before and After Dilatative Tracheotomy

November 12, 2020 updated by: Stefan Kluge

EIT: Changes of Pulmonary Ventilation Before and After Tracheotomy

The changes of local pulmonary ventilation should be registered with an electric impedance tomography (EIT) before and after a dilatative tracheotomy. The hypothesis is that the EIT cannot show changes in local ventilation due to the tracheotomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

29

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

  • Germany
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg Eppendorf
      • Hamburg, Germany, 20246
        • Universitätsklikum Hamburg Eppendorf

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 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ICU patients undergoing an elective dilatative tracheotomy. Before and after tracheotomy the results of EIT will be compared.

Description

Inclusion Criteria:

  • treatment on ICU
  • indication for tracheotomy
  • age between 18 and 85 years
  • written to consent

Exclusion Criteria:

  • severe chronic pulmonary disease
  • cardio pulmonary unstable situation

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
ICU patients undergoing a dilatative tracheotomy.
Other: EIT belt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
volume of ventilation, regional compliance.
Time Frame: Change from Baseline (2 Minutes preoperative) until 2 Minutes postoperative
measurement starts twenty minutes before surgery and ends after realised recruitment after tracheotomy.
Change from Baseline (2 Minutes preoperative) until 2 Minutes postoperative

Collaborators and Investigators

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

Sponsor

Stefan Kluge

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

February 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

July 15, 2015

Study Registration Dates

First Submitted

January 13, 2014

First Submitted That Met QC Criteria

June 9, 2014

First Posted (Estimate)

June 11, 2014

Study Record Updates

Last Update Posted (Actual)

November 16, 2020

Last Update Submitted That Met QC Criteria

November 12, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • EIT2014

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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