Chylothorax, Empyema, Hemothorax, Hydrothorax, Pneumothorax
Conditions
Keywords
Chest tube, placement, mal positioning
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.
Interventions
DEVICEKatGuide versus conventional method (forceps)
According to randomization Chest tubes are placed in the pleural cavity by using the KatGuide device.
PROCEDUREChest tube insertion
The chest tube is placed in the pleural cavity by using a forceps (conventional method) or KatGuide
Sponsors
University of Aarhus
Niels Katballe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chest tube placement | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | 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 | 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 | 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 | 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. |
Countries
Denmark
Outcome results
None listed