KatGuide Method Versus Conventional Method at Insertion of Chest Tube
This study is currently recruiting participants.
Verified August 2012 by University of Aarhus
Sponsor:
Niels Katballe
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
Niels Katballe, University of Aarhus
ClinicalTrials.gov Identifier:
NCT01522885
First received: January 24, 2012
Last updated: August 10, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumothorax Hydrothorax Hemothorax Empyema Chylothorax |
Device: KatGuide versus conventional method (forceps) Procedure: Chest tube insertion |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | KatGuide-trial. KatGuide Method Versus Conventional Method at Insertion of Chest Tube. A Randomized, Parallel Group, Controlled Trial. |
Resource links provided by NLM:
Further study details as provided by University of Aarhus:
Primary Outcome Measures:
- Chest tube placement [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]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 Outcome Measures:
- Length of hospital stay [ Time Frame: 5 days ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 240 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: KatGuide
Chest tube insertion is performed by using the KatGuide
|
Device: KatGuide versus conventional method (forceps)
According to randomization Chest tubes are placed in the pleural cavity by using the KatGuide device.
|
|
Active Comparator: Conventional group
Chest tubes are inserted by using conventional method (forceps) for large bore chest tube insertion.
|
Procedure: Chest tube insertion
The chest tube is placed in the pleural cavity by using a forceps (conventional method) or KatGuide
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522885
Contacts
| Contact: Niels Katballe, MD, PhD | +45 61 68 39 31 | katballe@dadlnet.dk |
Locations
| Denmark | |
| Niels Katballe | Not yet recruiting |
| Aarhus, Aarhus N, Denmark, 8200 | |
| Contact: Niels Katballe, MD, PhD +45 61683931 katballe@dadlnet.dk | |
| Principal Investigator: Peter Licht, Professor | |
| Principal Investigator: Vytautas Nekrasas, MD | |
| Sub-Investigator: Winnie Olesen, MD | |
| Sub-Investigator: Lars Møller, MD | |
| Principal Investigator: Hans Pilegaard, MD | |
| Vytautas Nekrasas | Recruiting |
| Aalborg, Denmark, 9000 | |
| Contact: Vytautas Nekrasas, MD +45 86628563 | |
| Contact: Lars Moeller, MD +45 51900475 | |
| Sub-Investigator: Lars Moeller, MD | |
| Niels Katballe | Recruiting |
| Aarhus N, Denmark, 8200 | |
| Contact: Niels Katballe +45 61683931 | |
| Sub-Investigator: Niels Katballe | |
| Peter B Licht | Recruiting |
| Odense, Denmark, 5000 | |
| Contact: Peter B Licht, professor +45 24777984 | |
| Sub-Investigator: Winnie H Olesen, MD | |
Sponsors and Collaborators
Niels Katballe
University of Aarhus
Investigators
| Study Director: | Niels Katballe, MD, PhD | University of Aarhus |
More Information
No publications provided
| Responsible Party: | Niels Katballe, Coordinating investigator, MD, PhD, University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT01522885 History of Changes |
| Other Study ID Numbers: | 2011375 |
| Study First Received: | January 24, 2012 |
| Last Updated: | August 10, 2012 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
Keywords provided by University of Aarhus:
|
Chest tube placement mal positioning |
Additional relevant MeSH terms:
|
Chylothorax Empyema Hemothorax Hydrothorax Pneumothorax Pleural Diseases |
Respiratory Tract Diseases Suppuration Infection Inflammation Pathologic Processes Hemorrhage |
ClinicalTrials.gov processed this record on June 18, 2013