KatGuide Method Versus Conventional Method at Insertion of Chest Tube

Sponsor

Niels Katballe (Other)

Overall Status

Completed

CT.gov ID

NCT01522885

Collaborator

University of Aarhus (Other)

109

Enrollment

Locations

Arms

Duration (Months)

27.3

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumothorax Hydrothorax Hemothorax Empyema Chylothorax	Device: KatGuide versus conventional method (forceps) Procedure: Chest tube insertion	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

109 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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.

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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