KatGuide Method Versus Conventional Method at Insertion of Chest Tube

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pneumothorax Hydrothorax Hemothorax Empyema Chylothorax

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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KatGuide

Chest tube insertion is performed by using the KatGuide

Group Type ACTIVE_COMPARATOR

KatGuide versus conventional method (forceps)

Intervention Type DEVICE

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

Conventional group

Chest tubes are inserted by using conventional method (forceps) for large bore chest tube insertion.

Group Type ACTIVE_COMPARATOR

Chest tube insertion

Intervention Type PROCEDURE

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

Interventions

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KatGuide versus conventional method (forceps)

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

Intervention Type DEVICE

Chest tube insertion

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No