KatGuide Method Versus Conventional Method at Insertion of Chest Tube

Phase 3

Completed

• Conditions: Pneumothorax; Hydrothorax; Hemothorax; Empyema; Chylothorax
• Interventions: Device: KatGuide versus conventional method (forceps); Procedure: Chest tube insertion

• Registration Number: NCT01522885
• Lead Sponsor: Niels Katballe

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-24
• Study First Submitted QC: 2012-01-27
• Study First Posted: 2012-02-01
• Study Start: 2012-04
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-19
• Last Update Posted: 2014-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KatGuide	KatGuide versus conventional method (forceps)	Chest tube insertion is performed by using the KatGuide
Conventional group	Chest tube insertion	Chest tubes are inserted by using conventional method (forceps) for large bore chest tube insertion.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (3)

Niels Katballe; 🇩🇰 Aarhus N, Denmark

Vytautas Nekrasas; 🇩🇰 Aalborg, Denmark

Peter B Licht; 🇩🇰 Odense, Denmark