KatGuide Method Versus Conventional Method at Insertion of Chest Tube (KatGuide)

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

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 Overview

• Status: Completed
• Conditions: Pneumothorax; Hemothorax; Empyema; Hydrothorax; Chylothorax
• Intervention / Treatment: Device: KatGuide versus conventional method (forceps); Procedure: Chest tube insertion

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Vytautas Nekrasas
  • Aarhus N, Denmark, 8200
    • Niels Katballe
  • Odense, Denmark, 5000
    • Peter B Licht
  • Aarhus N
    • Aarhus, Aarhus N, Denmark, 8200
      • Niels Katballe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	7 days (mean time)

Collaborators and Investigators

• Sponsor: Niels Katballe
• Collaborators: University of Aarhus
• Investigators: Study Director: Niels Katballe, MD, PhD, University of Aarhus

Publications and helpful links

General Publications

• Katballe N, Moeller LB, Olesen WH, Litzer MM, Andersen G, Nekrasas V, Licht PB, Bach P, Pilegaard HK. A Novel Device for Accurate Chest Tube Insertion: A Randomized Controlled Trial. Ann Thorac Surg. 2016 Feb;101(2):527-32. doi: 10.1016/j.athoracsur.2015.07.017. Epub 2015 Sep 26.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): May 1, 2014

Study Registration Dates

• First Submitted: January 24, 2012
• First Submitted That Met QC Criteria: January 27, 2012
• First Posted (ESTIMATE): February 1, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 21, 2014
• Last Update Submitted That Met QC Criteria: August 19, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: placement; Chest tube; mal positioning
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Diseases; Inflammation; Pleural Diseases; Hemorrhage; Suppuration; Pneumothorax; Hemothorax; Empyema; Hydrothorax; Chylothorax
• Other Study ID Numbers: 2011375