KatGuide Method Versus Conventional Method at Insertion of Chest Tube (KatGuide)
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|ClinicalTrials.gov Identifier: NCT01522885|
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : August 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pneumothorax Hydrothorax Hemothorax Empyema Chylothorax||Device: KatGuide versus conventional method (forceps) Procedure: Chest tube insertion||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||109 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||KatGuide-trial. KatGuide Method Versus Conventional Method at Insertion of Chest Tube. A Randomized, Parallel Group, Controlled Trial.|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Active Comparator: KatGuide
Chest tube insertion is performed by using the KatGuide
Device: KatGuide versus conventional method (forceps)
According to randomization Chest tubes are placed in the pleural cavity by using the KatGuide device.
Active Comparator: Conventional group
Chest tubes are inserted by using conventional method (forceps) for large bore chest tube insertion.
Procedure: Chest tube insertion
The chest tube is placed in the pleural cavity by using a forceps (conventional method) or KatGuide
- Chest tube placement [ Time Frame: 3 hours ]X-ray examination of the chest is performed within 3 hours after the chest tube insertion, to evaluate if the placement of the chest tube is acceptable.
- Length of hospital stay [ Time Frame: 5 days ]The hospital stay depends on how long time it takes to solve the chest tube related problem. In a few patients it takes only one day, but in severe cases it may take weeks before the patient can be discharged. We predict, that the patient will be in hospital for a mean time of 5 days.
- Time with chest tube [ Time Frame: 3 days (mean time) ]A few patients can have the chest tube removed in only one day, but some patients must have a chest tube for weeks. We predict that the patients will have a chest tube in a mean time of 3 days.
- Infection in wound [ Time Frame: 4 weeks ]4 weeks after the chest tube insertion, the patient is contacted and the patient is asked whether there are problems with infection of the wound.
- Number of chest tubes [ Time Frame: 7 days (mean time) ]It is observed whether the patient has multiple chest tubes inserted in the pleural cavity at the same side. It is predicted, that these patients are hospitalized longer than patients with only one chest tube. We predict, that these patients are hospitalized for a mean time of 7 days.
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 ClinicalTrials.gov identifier (NCT number): NCT01522885
|Aarhus, Aarhus N, Denmark, 8200|
|Aalborg, Denmark, 9000|
|Aarhus N, Denmark, 8200|
|Peter B Licht|
|Odense, Denmark, 5000|
|Study Director:||Niels Katballe, MD, PhD||University of Aarhus|