NCT01522885

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

August 21, 2014

Status Verified

August 1, 2014

Enrollment Period

2.1 years

First QC Date

January 24, 2012

Last Update Submit

August 19, 2014

Conditions

PneumothoraxHydrothoraxHemothoraxEmpyemaChylothorax

Keywords

Chest tubeplacementmal positioning

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Length of hospital stay

    5 days

  • Time with chest tube

    3 days (mean time)

  • Infection in wound

    4 weeks

  • Number of chest tubes

    7 days (mean time)

Study Arms (2)

KatGuide

ACTIVE COMPARATOR

Chest tube insertion is performed by using the KatGuide

Device: KatGuide versus conventional method (forceps)

Conventional group

ACTIVE COMPARATOR

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

Procedure: Chest tube insertion

Interventions

KatGuide versus conventional method (forceps)DEVICE

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

KatGuide
Chest tube insertionPROCEDURE

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

Conventional group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years of age or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Niels Katballe

Aarhus, Aarhus N, 8200, Denmark

Location

Vytautas Nekrasas

Aalborg, Denmark, 9000, Denmark

Location

Niels Katballe

Aarhus N, Denmark, 8200, Denmark

Location

Peter B Licht

Odense, Denmark, 5000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 26409714DERIVED

MeSH Terms

Conditions

PneumothoraxHydrothoraxHemothoraxEmpyemaChylothorax

Interventions

Surgical Instruments

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSuppurationInfectionsInflammation

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Study Officials

  • Niels Katballe, MD, PhD

    University of Aarhus

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Coordinating investigator, MD, PhD

Study Record Dates

First Submitted

January 24, 2012

First Posted

February 1, 2012

Study Start

April 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

August 21, 2014

Record last verified: 2014-08

Locations

DK(4)