KatGuide Method Versus Conventional Method at Insertion of Chest Tube

Niels Katballe109 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

109

Conditions

Pneumothorax Hydrothorax Hemothorax Empyema Chylothorax

Interventions

KatGuide versus conventional method (forceps)DEVICE

According to randomization Chest tubes are placed in the pleural cavity by using the KatGuide device.

Chest tube insertionPROCEDURE

The chest tube is placed in the pleural cavity by using a forceps (conventional method) or KatGuide

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Niels Katballe

Aarhus, Aarhus N, Denmark

Vytautas Nekrasas

Aalborg, Denmark, Denmark

Niels Katballe

Aarhus N, Denmark, Denmark

Peter B Licht

Odense, Denmark, Denmark

Outcomes

Primary Outcomes

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.

Time frame: 3 hours

Secondary Outcomes

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.

Time frame: 5 days

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.

Time frame: 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.

Time frame: 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.

Time frame: 7 days (mean time)

Data from ClinicalTrials.gov

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