Clinical Trial: KatGuide Method Versus Conventional Method at Insertion of Chest Tube

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: KatGuide-trial. KatGuide Method Versus Conventional Method at Insertion of Chest Tube. A Randomized, Parallel Group, Controlled Trial.

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 method.

Detailed Summary:
Sponsor: Niels Katballe

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: University of Aarhus

Dates:
Date Received: January 24, 2012
Date Started: April 2012
Date Completion:
Last Updated: August 19, 2014
Last Verified: August 2014