Pulmonary FistulaAATDNCT01177215
Investigation of an Adaptive Treatment Algorithm for Post-op Thoracic Patients to Reduce the Length of Drainage
An observational study of Pulmonary Fistula, run by Medela AG at 4 sites in Germany.
Trial summary
The purpose of this study is to reduce the length of drainage using a treatment protocol to control the manipulation of the applied vacuum to the pleural cavity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Fistula
- What is being tested?
- Thoracic Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 39 participants
- Where
- 4 sitesGermany
- Study dates
- Jul 2011to Nov 2012
- Phase
- Observational
- 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
Study population: Thoracic Surgery Patient
Who may be able to join
- Patients with a post operative air leak after 16 to 24 hours bigger than 50ml/min.
Who cannot join
- Patients with an empyema
- Patients with a spontaneous pneumothorax
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Klinikum Bremen-Ost
Bremen, Free Hanseatic City of Bremen, 28325
Universitätsklinik Freiburg
Freiburg im Breisgau, 79106
Klinik Schillerhöhe
Gerlingen, Gerlingen, 70839
Krankenhaus Großhansdorf
Großhansdorf, 22927
About this study
Official title: Implementation of an Adaptive Algorithm to Improve Chest Tube Therapy in Patients With Pulmonary Leaks Following Thoracic Surgery
The purpose of this study is to reduce the length of drainage using a treatment protocol to control the manipulation of the applied vacuum to the pleural cavity.
Read the detailed description
In this prospective study, a treatment algorithm is tested in a subgroup of patients with postoperative pulmo-pleural fistula. The primary aim is to reduce the duration of pulmo-pleural fistulation. Secondary aim is to reduce the duration of chest tube therapy.
- Conditions
- Pulmonary Fistula
- Being tested
- Thoracic Surgery
- Keywords
- Algorithm, Treatment Protocol, Thoracic Drainage Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic SurgeryProcedure or surgery
Also called Thopaz Drainage Device
Wedge Resection Segmental Resection Lobectomy
| Study group | Role | What they receive |
|---|---|---|
| Digital chest tube | All patients will be treated with the digital chest tube device Receives: Procedure: Thoracic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of pulmo-pleural fistulation
The duration of a postoperative pulmo-pleural fistula is monitored.
Measured: July 2011 - March 2012
Secondary outcomes (2)
Duration of Chest tube therapy
Duration of postoperative chest tube therapy is monitored.
Measured: July 2011 - March 2012
Applicability of a diagnostic "Leakage Scale"
Applicability of a generated scale that categorizes the pulmonary air leak is tested.
Measured: July 2011 - March 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startJul 2011
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: Interim analysis showed that the tested protocol did not improve treatment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pulmonary FistulaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medela AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Inez Cregan, Medela AG
- Investigators
- Thorsten Walles, MD FETCS, Principal investigator, Schillerhoehe Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177215
- Sponsor's protocol ID
- GE-ADAPTALGO-2010
- Acronym
- AATD
- Status last verified
- May 2013
- First submitted
- 4 Aug 2010
- Last updated
- 7 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alex J, Ansari J, Bahalkar P, Agarwala S, Rehman MU, Saleh A, Cowen ME. Comparison of the immediate postoperative outcome of using the conventional two drains versus a single drain after lobectomy. Ann Thorac Surg. 2003 Oct;76(4):1046-9. doi: 10.1016/s0003-4975(03)00884-1.
PubMed 14529982Baumann MH. What size chest tube? What drainage system is ideal? And other chest tube management questions. Curr Opin Pulm Med. 2003 Jul;9(4):276-81. doi: 10.1097/00063198-200307000-00006.
PubMed 12806240Brunelli A, Sabbatini A, Xiume' F, Refai MA, Salati M, Marasco R. Alternate suction reduces prolonged air leak after pulmonary lobectomy: a randomized comparison versus water seal. Ann Thorac Surg. 2005 Sep;80(3):1052-5. doi: 10.1016/j.athoracsur.2005.03.073.
PubMed 16122484Cerfolio RJ, Bryant AS. The benefits of continuous and digital air leak assessment after elective pulmonary resection: a prospective study. Ann Thorac Surg. 2008 Aug;86(2):396-401. doi: 10.1016/j.athoracsur.2008.04.016.
PubMed 18640304Varela G, Jimenez MF, Novoa NM, Aranda JL. Postoperative chest tube management: measuring air leak using an electronic device decreases variability in the clinical practice. Eur J Cardiothorac Surg. 2009 Jan;35(1):28-31. doi: 10.1016/j.ejcts.2008.09.005. Epub 2008 Oct 9.
PubMed 18848460
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an Adaptive Algorithm to Improve Chest Tube Therapy in Patients With Pulmonary Leaks Following Thoracic Surgery
- ClinicalTrials.gov ID
- NCT01177215
- Acronym / sponsor ID
- AATD / GE-ADAPTALGO-2010
- Conditions
- Pulmonary Fistula
- Keywords
- Algorithm, Treatment Protocol, Thoracic Drainage Device
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Interim analysis showed that the tested protocol did not improve treatment
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Medela AGIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 6 Aug 2010 (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 reduce the length of drainage using a treatment protocol to control the manipulation of the applied vacuum to the pleural cavity.
Detailed description
In this prospective study, a treatment algorithm is tested in a subgroup of patients with postoperative pulmo-pleural fistula. The primary aim is to reduce the duration of pulmo-pleural fistulation. Secondary aim is to reduce the duration of chest tube therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital chest tube | – | Procedure: Thoracic SurgeryAll patients will be treated with the digital chest tube device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thoracic Surgery Patient
Key inclusion criteria (1 listed)
- Patients with a post operative air leak after 16 to 24 hours bigger than 50ml/min.
Key exclusion criteria (2 listed)
- Patients with an empyema
- Patients with a spontaneous pneumothorax
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 |
|---|---|---|
| Thoracic SurgeryAlso: Thopaz Drainage DeviceWedge Resection Segmental Resection Lobectomy | Procedure or surgery | Digital chest tube |
Primary outcome
Duration of pulmo-pleural fistulation
Time frame: July 2011 - March 2012
The duration of a postoperative pulmo-pleural fistula is monitored.
2 secondary outcomes
Duration of Chest tube therapy
Time frame: July 2011 - March 2012
Applicability of a diagnostic "Leakage Scale"
Time frame: July 2011 - March 2012
Results and safety
The study was stopped early (reason given: Interim analysis showed that the tested protocol did not improve treatment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2013.
- Background: PubMed 14529982Alex J, Ansari J, Bahalkar P, Agarwala S, Rehman MU, Saleh A, Cowen ME. Comparison of the immediate postoperative outcome of using the conventional two drains versus a single drain after lobectomy. Ann Thorac Surg. 2003 Oct;76(4):1046-9. doi: 10.1016/s0003-4975(03)00884-1.
- Background: PubMed 12806240Baumann MH. What size chest tube? What drainage system is ideal? And other chest tube management questions. Curr Opin Pulm Med. 2003 Jul;9(4):276-81. doi: 10.1097/00063198-200307000-00006.
- Background: PubMed 16122484Brunelli A, Sabbatini A, Xiume' F, Refai MA, Salati M, Marasco R. Alternate suction reduces prolonged air leak after pulmonary lobectomy: a randomized comparison versus water seal. Ann Thorac Surg. 2005 Sep;80(3):1052-5. doi: 10.1016/j.athoracsur.2005.03.073.
- Background: PubMed 18640304Cerfolio RJ, Bryant AS. The benefits of continuous and digital air leak assessment after elective pulmonary resection: a prospective study. Ann Thorac Surg. 2008 Aug;86(2):396-401. doi: 10.1016/j.athoracsur.2008.04.016.
- Background: PubMed 18848460Varela G, Jimenez MF, Novoa NM, Aranda JL. Postoperative chest tube management: measuring air leak using an electronic device decreases variability in the clinical practice. Eur J Cardiothorac Surg. 2009 Jan;35(1):28-31. doi: 10.1016/j.ejcts.2008.09.005. Epub 2008 Oct 9.
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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.
Thorsten Walles, MD FETCS principal investigator
Schillerhoehe Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Fistula, run by Medela AG at 4 sites in Germany.
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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 7 May 2013. 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 Germany. 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.
Are results available for this study?
The study was stopped early (reason given: Interim analysis showed that the tested protocol did not improve treatment). Results are not available in the source record.
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?
Duration of pulmo-pleural fistulation (time frame: July 2011 - March 2012). 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 NCT01177215, which also lists 5 linked publications.
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 7 May 2013.