Status:
COMPLETED
KatGuide Method Versus Conventional Method at Insertion of Chest Tube
Lead Sponsor:
Niels Katballe
Collaborating Sponsors:
University of Aarhus
Conditions:
Pneumothorax
Hydrothorax
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate whether if KatGuide (a new developed medical device) improves the placing of a large bore chest tube in the pleural cavity compared to the conventional meth...
Eligibility Criteria
Inclusion
- Patients with pneumothorax in the upper pleural space or fluid in the lower pleural space.
- Indication for upper or lower placement of a single chest tube in the pleural cavity
- 18 years of age or older
Exclusion
- Fertile women
- Patients who can not give written or verbal consent to participate
- If there is no time or possibility to inform the patient
- Patients who already has a large bore chest tube
- Patients with long lasting (\>14 days) or chronic chest tube
- Patients with both fluid and air in the pleural cavity
- Patients where "the safe area" (front axillary fold, IC 4-5) can not be used for chest tube insertion
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT01522885
Start Date
April 1 2012
End Date
May 1 2014
Last Update
August 21 2014
Active Locations (4)
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1
Niels Katballe
Aarhus, Aarhus N, Denmark, 8200
2
Vytautas Nekrasas
Aalborg, Denmark, Denmark, 9000
3
Niels Katballe
Aarhus N, Denmark, Denmark, 8200
4
Peter B Licht
Odense, Denmark, Denmark, 5000