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Completed

NCT Number: NCT01522885

KatGuide Method Versus Conventional Method at Insertion of Chest Tube

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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Key information

Conditions

Pneumothorax Chylothorax Empyema Hemorrhage Hemothorax Hydrothorax Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Pleural Diseases Respiratory Tract Diseases Suppuration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Niels Katballe, Aarhus, Aarhus N, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KatGuide versus conventional method (forceps)

Device

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

Chest tube insertion

Procedure

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

Primary outcomes

  1. Chest tube placement

    Time frame: 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 outcomes

  1. Length of hospital stay

    Time frame: 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.

  2. Time with chest tube

    Time frame: 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.

  3. Infection in wound

    Time frame: 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.

  4. Number of chest tubes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Niels Katballe

Other

Collaborators

  • University of Aarhus

Registry information

Official study title

KatGuide-trial. KatGuide Method Versus Conventional Method at Insertion of Chest Tube. A Randomized, Parallel Group, Controlled Trial.

Acronym: KatGuide

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 1, 2012
Registry last updated
Aug 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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