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| Name | Class |
|---|---|
| University of Aarhus | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KatGuide | Active Comparator | Chest tube insertion is performed by using the KatGuide |
|
| Conventional group | Active Comparator | Chest tubes are inserted by using conventional method (forceps) for large bore chest tube insertion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KatGuide versus conventional method (forceps) | Device | According to randomization Chest tubes are placed in the pleural cavity by using the KatGuide device. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niels Katballe, MD, PhD | University of Aarhus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Niels Katballe | Aarhus | Aarhus N | 8200 | Denmark | ||
| Vytautas Nekrasas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26409714 | Derived | Katballe N, Moeller LB, Olesen WH, Litzer MM, Andersen G, Nekrasas V, Licht PB, Bach P, Pilegaard HK. A Novel Device for Accurate Chest Tube Insertion: A Randomized Controlled Trial. Ann Thorac Surg. 2016 Feb;101(2):527-32. doi: 10.1016/j.athoracsur.2015.07.017. Epub 2015 Sep 26. |
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| ID | Term |
|---|---|
| D011030 | Pneumothorax |
| D006876 | Hydrothorax |
| D006491 | Hemothorax |
| D004653 | Empyema |
| D002916 | Chylothorax |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D013525 | Surgical Instruments |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Chest tube insertion | Procedure | The chest tube is placed in the pleural cavity by using a forceps (conventional method) or KatGuide |
|
| 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) |
| Aalborg |
| Denmark |
| 9000 |
| Denmark |
| Niels Katballe | Aarhus N | Denmark | 8200 | Denmark |
| Peter B Licht | Odense | Denmark | 5000 | Denmark |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013492 | Suppuration |
| D007239 | Infections |
| D007249 | Inflammation |