ICU PatientsNCT02161328
Electric Impedance Tomography Before and After Dilatative Tracheotomy
An observational study of ICU Patients and Tracheotomy Required, run by Stefan Kluge at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ICU Patients, Tracheotomy Required
- What is being tested?
- EIT belt
- How many people
- 29 participants
- Where
- 2 sitesGermany
- Study dates
- Feb 2014to 15 Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU patients undergoing an elective dilatative tracheotomy. Before and after tracheotomy the results of EIT will be compared.
Who may be able to join
- treatment on ICU
- indication for tracheotomy
- age between 18 and 85 years
- written to consent
Who cannot join
- severe chronic pulmonary disease
- cardio pulmonary unstable situation
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Universitätsklikum Hamburg Eppendorf
Hamburg, 20246
Universitätsklinikum Hamburg Eppendorf
Hamburg, 20246
About this study
Official title: 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.
- Conditions
- ICU Patients, Tracheotomy Required
- Being tested
- EIT belt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EIT beltOther
| Study group | Role | What they receive |
|---|---|---|
| ICU patients undergoing a dilatative tracheotomy. | Not described Receives: Other: EIT belt |
What is being measured
The primary outcome is the main question the study is designed to answer.
volume of ventilation, regional compliance.
measurement starts twenty minutes before surgery and ends after realised recruitment after tracheotomy.
Measured: Change from Baseline (2 Minutes preoperative) until 2 Minutes postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completion15 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ICU PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stefan Kluge
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefan Kluge, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161328
- Sponsor's protocol ID
- EIT2014
- Status last verified
- Nov 2020
- First submitted
- 13 Jan 2014
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Eichler L, Mueller J, Grensemann J, Frerichs I, Zollner 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 Intensive Care. 2018 Nov 15;8(1):110. doi: 10.1186/s13613-018-0454-y.
PubMed 30443867
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EIT: Changes of Pulmonary Ventilation Before and After Tracheotomy
- ClinicalTrials.gov ID
- NCT02161328
- Acronym / sponsor ID
- EIT2014
- Conditions
- ICU Patients, Tracheotomy Required
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Stefan KlugeUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- 15 Jul 2015 (actual)
- First posted
- 11 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients undergoing a dilatative tracheotomy. | – | Other: EIT belt |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients undergoing an elective dilatative tracheotomy. Before and after tracheotomy the results of EIT will be compared.
Key inclusion criteria (4 listed)
- treatment on ICU
- indication for tracheotomy
- age between 18 and 85 years
- written to consent
Key exclusion criteria (2 listed)
- severe chronic pulmonary disease
- cardio pulmonary unstable situation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EIT belt | Other | ICU patients undergoing a dilatative tracheotomy. |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Results publication: PubMed 30443867Eichler L, Mueller J, Grensemann J, Frerichs I, Zollner 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 Intensive Care. 2018 Nov 15;8(1):110. doi: 10.1186/s13613-018-0454-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ICU Patients and Tracheotomy Required, run by Stefan Kluge at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
volume of ventilation, regional compliance. (time frame: Change from Baseline (2 Minutes preoperative) until 2 Minutes postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02161328, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.