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Electric Impedance Tomography Before and After Dilatative Tracheotomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02161328
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : November 16, 2020
Information provided by (Responsible Party):
Stefan Kluge, Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
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.

Condition or disease Intervention/treatment
ICU Patients Tracheotomy Required Other: EIT belt

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Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: EIT: Changes of Pulmonary Ventilation Before and After Tracheotomy
Study Start Date : February 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : July 15, 2015

Group/Cohort Intervention/treatment
ICU patients undergoing a dilatative tracheotomy. Other: EIT belt

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02161328

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Universitätsklikum Hamburg Eppendorf
Hamburg, Germany, 20246
Universitätsklinikum Hamburg Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Stefan Kluge
Publications of Results:
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Responsible Party: Stefan Kluge, medical director, Universitätsklinikum Hamburg-Eppendorf Identifier: NCT02161328    
Other Study ID Numbers: EIT2014
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020