KatGuide Method Versus Conventional Method at Insertion of Chest Tube

This study has been completed.
Sponsor:
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
Niels Katballe, University of Aarhus
ClinicalTrials.gov Identifier:
NCT01522885
First received: January 24, 2012
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Pneumothorax
Hydrothorax
Hemothorax
Empyema
Chylothorax
Device: KatGuide versus conventional method (forceps)
Procedure: Chest tube insertion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: KatGuide-trial. KatGuide Method Versus Conventional Method at Insertion of Chest Tube. A Randomized, Parallel Group, Controlled Trial.

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Chest tube placement [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]
    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:
  • Length of hospital stay [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 days (mean time) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 7 days (mean time) ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 109
Study Start Date: April 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: KatGuide
Chest tube insertion is performed by using the KatGuide
Device: KatGuide versus conventional method (forceps)
According to randomization Chest tubes are placed in the pleural cavity by using the KatGuide device.
Active Comparator: Conventional group
Chest tubes are inserted by using conventional method (forceps) for large bore chest tube insertion.
Procedure: Chest tube insertion
The chest tube is placed in the pleural cavity by using a forceps (conventional method) or KatGuide

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01522885

Locations
Denmark
Niels Katballe
Aarhus, Aarhus N, Denmark, 8200
Vytautas Nekrasas
Aalborg, Denmark, 9000
Niels Katballe
Aarhus N, Denmark, 8200
Peter B Licht
Odense, Denmark, 5000
Sponsors and Collaborators
Niels Katballe
University of Aarhus
Investigators
Study Director: Niels Katballe, MD, PhD University of Aarhus
  More Information

No publications provided

Responsible Party: Niels Katballe, Coordinating investigator, MD, PhD, University of Aarhus
ClinicalTrials.gov Identifier: NCT01522885     History of Changes
Other Study ID Numbers: 2011375
Study First Received: January 24, 2012
Last Updated: August 19, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Chest tube
placement
mal positioning

Additional relevant MeSH terms:
Chylothorax
Empyema
Hemothorax
Hydrothorax
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases
Suppuration
Infection
Inflammation
Pathologic Processes
Hemorrhage

ClinicalTrials.gov processed this record on August 20, 2014