PneumothoraxPhase 3KatGuideNCT01522885
KatGuide Method Versus Conventional Method at Insertion of Chest Tube
A Phase 3 study testing KatGuide versus conventional method (forceps) and Chest tube insertion in people with Pneumothorax and Hydrothorax, run by Niels Katballe at 4 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumothorax, Hydrothorax, Hemothorax
- What is being tested?
- KatGuide versus conventional method (forceps) and Chest tube insertion
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 4 sitesDenmark
- Study dates
- Apr 2012to May 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Vytautas Nekrasas
Aalborg, Denmark, 9000
Niels Katballe
Aarhus, Aarhus N, 8200
Niels Katballe
Aarhus N, Denmark, 8200
Peter B Licht
Odense, Denmark, 5000
About this study
Official title: 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.
- Conditions
- Pneumothorax, Hydrothorax, Hemothorax, Empyema, Chylothorax
- Being tested
- KatGuide versus conventional method (forceps), Chest tube insertion
- Keywords
- Chest tube, placement, mal positioning
- Medical subject headings
- Pneumothorax, Hydrothorax, Hemothorax, Empyema, Chylothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KatGuide versus conventional method (forceps)Device
According to randomization Chest tubes are placed in the pleural cavity by using the KatGuide device.
Chest tube insertionProcedure or surgery
The chest tube is placed in the pleural cavity by using a forceps (conventional method) or KatGuide
| Study group | Role | What they receive |
|---|---|---|
| KatGuide | Active comparator | Chest tube insertion is performed by using the KatGuide Receives: 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. Receives: Procedure: Chest tube insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 hours
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 days (mean time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumothoraxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niels Katballe
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Sponsor-investigator, Niels Katballe, University of Aarhus
- Investigators
- Niels Katballe, MD, PhD, Study director, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522885
- Sponsor's protocol ID
- 2011375
- Acronym
- KatGuide
- Status last verified
- Aug 2014
- First submitted
- 24 Jan 2012
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26409714
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KatGuide-trial. KatGuide Method Versus Conventional Method at Insertion of Chest Tube. A Randomized, Parallel Group, Controlled Trial.
- ClinicalTrials.gov ID
- NCT01522885
- Acronym / sponsor ID
- KatGuide / 2011375
- Conditions
- Pneumothorax, Hydrothorax, Hemothorax, Empyema, Chylothorax
- Keywords
- Chest tube, placement, mal positioning
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Niels KatballeUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- Apr 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KatGuide | Active comparator | Device: KatGuide versus conventional method (forceps)Chest tube insertion is performed by using the KatGuide |
| Conventional group | Active comparator | Procedure: Chest tube insertionChest tubes are inserted by using conventional method (forceps) for large bore chest tube insertion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KatGuide versus conventional method (forceps)According to randomization Chest tubes are placed in the pleural cavity by using the KatGuide device. | Device | KatGuide |
| Chest tube insertionThe chest tube is placed in the pleural cavity by using a forceps (conventional method) or KatGuide | Procedure or surgery | Conventional group |
Primary outcome
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.
4 secondary outcomes
Length of hospital stay
Time frame: 5 days
Time with chest tube
Time frame: 3 days (mean time)
Infection in wound
Time frame: 4 weeks
Number of chest tubes
Time frame: 7 days (mean time)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2014.
- Derived from this study: PubMed 26409714Katballe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels Katballe, MD, PhD study director
University of Aarhus
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KatGuide versus conventional method (forceps) and Chest tube insertion in people with Pneumothorax and Hydrothorax, run by Niels Katballe at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest tube placement (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01522885, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2014.