Pulmonary Air LeakNCT01467622
Effects of Local Protocols on Duration of Chest Tube Therapy Following Thoracic Surgery
An observational study of Pulmonary Air Leak, run by Schillerhoehe Hospital at 4 sites in Germany.
Trial summary
The effect of local chest-tube management protocols on the duration of chest-tube therapy following thoracic surgery was analyzed in four German specialized Thoracic Surgery Units. The primary study objective was the duration of chest tube therapy in postoperative patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pulmonary Air Leak
- What is being tested?
- Chest tube removal
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 4 sitesGermany
- Study dates
- Apr 2009to Oct 2011
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing pulmonary resection at one of the four participating thoracic surgery specialist units
Who may be able to join
- age 18-85
- following pulmonary wedge resection, anatomic segmentectomy, or lobectomy
Who cannot join
- surgery for spontaneous pneumothorax (primary and secondary)
- surgery for pleural empyema
- present medication with corticoids, immunosuppressive drugs or platelet aggregation inhibitors other than Aspirin
- history of chemotherapy, radiotherapy of the chest, or previous ipsilateral thoracic surgery
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Evangelische Lungenklinik Berlin
Berlin, 13125
Klinikum Bremen-Ost gGmbH
Bremen, 28325
Klinik Schillerhoehe
Gerlingen, 70839
Katholisches Klinikum Koblenz
Koblenz, 56073
About this study
Official title: Prospective, Non Randomized Investigator Initiated Multi-centre Trial on the Effects of Local Treatment Protocols on the Duration of Chest Tube Therapy Following Thoracic Surgery in Germany
The effect of local chest-tube management protocols on the duration of chest-tube therapy following thoracic surgery was analyzed in four German specialized Thoracic Surgery Units. The primary study objective was the duration of chest tube therapy in postoperative patients.
Read the detailed description
The management of chest tubes is probably one of the most critical aspects in patient care in thoracic surgery and defines the required length of postoperative hospital stay in the majority of patients. So far, no generally accepted recommendations exist for postoperative chest tube management to streamline the postoperative stay. Instead, decision making in most thoracic surgery units is based on team preferences and individual training rather than scientific data. Therefore, digital pleural drainage systems represent a useful tool to standardize existing intradepartmental protocols for chest tube management. However, for the development of generally accepted protocol-recommendations, the diverging interdepartmental treatment protocols have to be analyzed and compared for superiority. In this IIT, the effect of different chest tube management protocols on chest tube duration is analyzed in four German Thoracic Surgery units.
- Conditions
- Pulmonary Air Leak
- Being tested
- Chest tube removal
- Keywords
- chest tube drainage, pulmonary air leak, lung resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest tube removalProcedure or surgery
Chest tube removal on the basis of local recommendations for postoperative chest tube management
| Study group | Role | What they receive |
|---|---|---|
| Study population | Patients undergoing elective pulmonary wedge resection, anatomic segmentectomy, or lobectomy. Receives: Procedure: Chest tube removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
chest tube therapy duration
number of days following thoracic surgery until chest tube was removed
Measured: participants are followed for the duration of hospital stay, an expected average of 5 days
Secondary outcomes (1)
presence of pulmonary air leak
number of days the Medela Thopaz device detected a pulmonary air leak following thoracic surgery
Measured: participants are followed for the duration of hospital stay, an expected average of 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startApr 2009
- Primary completionAug 2009
- Study completionOct 2011
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 Pulmonary Air LeakStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schillerhoehe Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medela AG
- Responsible party
- Principal investigator, Thorsten Walles, Schillerhoehe Hospital
- Investigators
- Albert Linder, MD, Study director, Klinikum Bremen-Ost gGmbHThorsten Walles, MD, Principal investigator, Schillerhoehe HospitalJosef Wolf, Study chair, Medela GmbH & Co. Handels KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467622
- Sponsor's protocol ID
- KSH-TCH-IIT-2009-1
- Status last verified
- May 2013
- First submitted
- 30 Oct 2011
- Last updated
- 7 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Linder A, Ertner C, Steger V, Messerschmidt A, Merk J, Cregan I, Timm J, Walles T. Postoperative chest tube management: snapshot of German diversity. Interact Cardiovasc Thorac Surg. 2012 Oct;15(4):622-6. doi: 10.1093/icvts/ivs270. Epub 2012 Jun 29.
PubMed 22753431
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
- Prospective, Non Randomized Investigator Initiated Multi-centre Trial on the Effects of Local Treatment Protocols on the Duration of Chest Tube Therapy Following Thoracic Surgery in Germany
- ClinicalTrials.gov ID
- NCT01467622
- Acronym / sponsor ID
- KSH-TCH-IIT-2009-1
- Conditions
- Pulmonary Air Leak
- Keywords
- chest tube drainage, pulmonary air leak, lung resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Schillerhoehe HospitalUniversity, hospital or other
- Collaborators
- Medela AG
- Study start
- Apr 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 9 Nov 2011 (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 effect of local chest-tube management protocols on the duration of chest-tube therapy following thoracic surgery was analyzed in four German specialized Thoracic Surgery Units. The primary study objective was the duration of chest tube therapy in postoperative patients.
Detailed description
The management of chest tubes is probably one of the most critical aspects in patient care in thoracic surgery and defines the required length of postoperative hospital stay in the majority of patients. So far, no generally accepted recommendations exist for postoperative chest tube management to streamline the postoperative stay. Instead, decision making in most thoracic surgery units is based on team preferences and individual training rather than scientific data. Therefore, digital pleural drainage systems represent a useful tool to standardize existing intradepartmental protocols for chest tube management. However, for the development of generally accepted protocol-recommendations, the diverging interdepartmental treatment protocols have to be analyzed and compared for superiority. In this IIT, the effect of different chest tube management protocols on chest tube duration is analyzed in four German Thoracic Surgery units.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Procedure: Chest tube removalPatients undergoing elective pulmonary wedge resection, anatomic segmentectomy, or lobectomy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing pulmonary resection at one of the four participating thoracic surgery specialist units
Key inclusion criteria (2 listed)
- age 18-85
- following pulmonary wedge resection, anatomic segmentectomy, or lobectomy
Key exclusion criteria (4 listed)
- surgery for spontaneous pneumothorax (primary and secondary)
- surgery for pleural empyema
- present medication with corticoids, immunosuppressive drugs or platelet aggregation inhibitors other than Aspirin
- history of chemotherapy, radiotherapy of the chest, or previous ipsilateral thoracic surgery
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 |
|---|---|---|
| Chest tube removalChest tube removal on the basis of local recommendations for postoperative chest tube management | Procedure or surgery | Study population |
Primary outcome
chest tube therapy duration
Time frame: participants are followed for the duration of hospital stay, an expected average of 5 days
number of days following thoracic surgery until chest tube was removed
1 secondary outcome
presence of pulmonary air leak
Time frame: participants are followed for the duration of hospital stay, an expected average of 4 days
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 7 May 2013.
- Results publication: PubMed 22753431Linder A, Ertner C, Steger V, Messerschmidt A, Merk J, Cregan I, Timm J, Walles T. Postoperative chest tube management: snapshot of German diversity. Interact Cardiovasc Thorac Surg. 2012 Oct;15(4):622-6. doi: 10.1093/icvts/ivs270. Epub 2012 Jun 29.
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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.
Albert Linder, MD study director
Klinikum Bremen-Ost gGmbH
Thorsten Walles, MD principal investigator
Schillerhoehe Hospital
Josef Wolf study chair
Medela GmbH & Co. Handels KG
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 Air Leak, run by Schillerhoehe Hospital 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 2 inclusion and 4 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 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 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 therapy duration (time frame: participants are followed for the duration of hospital stay, an expected average of 5 days). 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 NCT01467622, 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 7 May 2013.