KatGuide Method Versus Conventional Method at Insertion of Chest Tube

Pneumothorax Clinical Trial

— KatGuide  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01522885
• Other study ID #: 2011375
• Status: Completed
• Phase: Phase 3
• First received: January 24, 2012
• Last updated: August 19, 2014
• Start date: April 2012
• Est. completion date: May 2014

Study information

• Verified date: August 2014
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chylothorax
• Empyema
• Hemothorax
• Hydrothorax
• Pneumothorax

Intervention

Device:
• KatGuide versus conventional method (forceps)
According to randomization Chest tubes are placed in the pleural cavity by using the KatGuide device.

Procedure:
• Chest tube insertion
The chest tube is placed in the pleural cavity by using a forceps (conventional method) or KatGuide

Locations

Country	Name	City	State
Denmark	Vytautas Nekrasas	Aalborg
Denmark	Niels Katballe	Aarhus	Aarhus N
Denmark	Niels Katballe	Aarhus N
Denmark	Peter B Licht	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Niels Katballe	University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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)	No
Secondary	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	Yes
Secondary	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)	Yes