KatGuide Method Versus Conventional Method at Insertion of Chest Tube

Study Overview
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Brief Summary
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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.

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

Conditions
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Pneumothorax, Hydrothorax, Hemothorax, Empyema, Chylothorax

Intervention / Treatment
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* Device: KatGuide versus conventional method (forceps)
* Procedure: Chest tube insertion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: KatGuide<br>Chest tube insertion is performed by using the KatGuide | Device: KatGuide versus conventional method (forceps)<br>* According to randomization Chest tubes are placed in the pleural cavity by using the KatGuide device.<br>|
| Active Comparator: Conventional group<br>Chest tubes are inserted by using conventional method (forceps) for large bore chest tube insertion. | Procedure: Chest tube insertion<br>* The chest tube is placed in the pleural cavity by using a forceps (conventional method) or KatGuide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 7 days (mean time) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chest tube, placement, mal positioning