ICU Patients Clinical Trial
Official title:
EIT: Changes of Pulmonary Ventilation Before and After Tracheotomy
| NCT number | NCT02161328 |
| Other study ID # | EIT2014 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 2014 |
| Est. completion date | July 15, 2015 |
| Verified date | November 2020 |
| Source | Universitätsklinikum Hamburg-Eppendorf |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 29 |
| Est. completion date | July 15, 2015 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Universitätsklikum Hamburg Eppendorf | Hamburg | |
| Germany | Universitätsklinikum Hamburg Eppendorf | Hamburg |
| Lead Sponsor | Collaborator |
|---|---|
| Stefan Kluge |
Germany,
Eichler L, Mueller J, Grensemann J, Frerichs I, Zöllner C, Kluge S. Lung aeration and ventilation after percutaneous tracheotomy measured by electrical impedance tomography in non-hypoxemic critically ill patients: a prospective observational study. Ann I — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | volume of ventilation, regional compliance. | measurement starts twenty minutes before surgery and ends after realised recruitment after tracheotomy. | Change from Baseline (2 Minutes preoperative) until 2 Minutes postoperative |
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