KatGuide Method Versus Conventional Method at Insertion of Chest Tube

Niels Katballe

Status and phase: Completed; Phase 3

Conditions: Pneumothorax; Hemothorax; Chylothorax; Empyema; Hydrothorax

Treatments: Procedure: Chest tube insertion; Device: KatGuide versus conventional method (forceps)

Study type: Interventional

Funder types: Other

Identifiers

NCT01522885

2011375

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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109 participants in 2 patient groups

KatGuide

Active Comparator group

Description:

Chest tube insertion is performed by using the KatGuide

Treatment:

Device: KatGuide versus conventional method (forceps)

Conventional group

Active Comparator group

Description:

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

Treatment:

Procedure: Chest tube insertion