NCT02161328

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2014

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 11, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2015

Completed
Last Updated

November 16, 2020

Status Verified

November 1, 2020

Enrollment Period

10 months

First QC Date

January 13, 2014

Last Update Submit

November 12, 2020

Conditions

ICU PatientsTracheotomy Required

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

ICU patients undergoing a dilatative tracheotomy.

Other: EIT belt

Interventions

EIT beltOTHER
ICU patients undergoing a dilatative tracheotomy.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • severe chronic pulmonary disease
  • cardio pulmonary unstable situation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitätsklikum Hamburg Eppendorf

Hamburg, 20246, Germany

Location

Universitätsklinikum Hamburg Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (1)

  • 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.

    PMID: 30443867RESULT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
medical director

Study Record Dates

First Submitted

January 13, 2014

First Posted

June 11, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2014

Study Completion

July 15, 2015

Last Updated

November 16, 2020

Record last verified: 2020-11

Locations

DE(2)