A Phase 3 interventional study of KatGuide versus conventional method (forceps) and Chest tube insertion in Pneumothorax, Hydrothorax and Hemothorax, sponsored by Niels Katballe. Completed at 4 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-21.
Sponsored by Niels Katballe · Phase 3, Interventional, and Treatment
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 method.
183 studies on the registry are indexed under Pneumothorax; 41 are open to participants now.
This study's enrollment of 109 is close to the median of 100 across 111 interventional studies indexed under Pneumothorax.
Browse Pneumothorax studies →This is the only study on the registry with Niels Katballe as lead sponsor.
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Exclusion Criteria:
Chest tube insertion is performed by using the KatGuide
Device: KatGuide versus conventional method (forceps)
Chest tubes are inserted by using conventional method (forceps) for large bore chest tube insertion.
Procedure: Chest tube insertion
According to randomization Chest tubes are placed in the pleural cavity by using the KatGuide device.
The chest tube is placed in the pleural cavity by using a forceps (conventional method) or KatGuide
Chest tube placement
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.
Time frame: 3 hours
Length of hospital stay
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 frame: 5 days
Time with chest tube
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.
Time frame: 3 days (mean time)
Infection in wound
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.
Time frame: 4 weeks
Number of chest tubes
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.
Time frame: 7 days (mean time)
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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