Back to results

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

Primary Purpose

Pneumothorax, Hydrothorax, Hemothorax

Status

Completed

Phase

Phase 3

Locations

Denmark

Study Type

Interventional

Intervention

KatGuide versus conventional method (forceps)

Chest tube insertion

About this trial

This is an interventional treatment trial for Pneumothorax focused on measuring Chest tube, placement, mal positioning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Niels Katballe
Vytautas Nekrasas
Niels Katballe
Peter B Licht

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

KatGuide

Conventional group

Arm Description

Chest tube insertion is performed by using the KatGuide

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT01522885

First Posted

January 24, 2012

Last Updated

August 19, 2014

Sponsor

Niels Katballe

Collaborators

University of Aarhus

1. Study Identification

Unique Protocol Identification Number

NCT01522885

Brief Title

KatGuide Method Versus Conventional Method at Insertion of Chest Tube

Acronym

KatGuide

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Niels Katballe

Collaborators

University of Aarhus

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumothorax, Hydrothorax, Hemothorax, Empyema, Chylothorax

Keywords

Chest tube, placement, mal positioning

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

109 (Actual)

8. Arms, Groups, and Interventions

Arm Title

KatGuide

Arm Type

Active Comparator

Arm Description

Chest tube insertion is performed by using the KatGuide

Arm Title

Conventional group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

KatGuide versus conventional method (forceps)

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Chest tube insertion

Intervention Description

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

Primary Outcome Measure Information:

Title

Chest tube placement

Description

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.

Time Frame

3 hours

Secondary Outcome Measure Information:

Title

Length of hospital stay

Description

Time Frame

5 days

Title

Time with chest tube

Description

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.

Time Frame

3 days (mean time)

Title

Infection in wound

Description

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.

Time Frame

4 weeks

Title

Number of chest tubes

Description

Time Frame

7 days (mean time)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Niels Katballe, MD, PhD

Organizational Affiliation

University of Aarhus

Official's Role

Study Director

Facility Information:

Facility Name

Niels Katballe

City

Aarhus

State/Province

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Vytautas Nekrasas

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Facility Name

Niels Katballe

City

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Peter B Licht

City

Odense

ZIP/Postal Code

5000

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

26409714

Citation

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.

Results Reference

derived

Learn more about this trial

KatGuide Method Versus Conventional Method at Insertion of Chest Tube

We'll reach out to this number within 24 hrs