Respiration DisordersNCT00530491
Prospective Trial to Reduce Morbidity and Mortality After Lung Surgery in Patients With Reduced Pulmonary Capacity
A study testing Fast track lung surgery in people with Respiration Disorders, run by University of Ulm at 1 site in Germany.
Trial summary
A fast track recovery program (thoracic epidural anesthesia, carbohydrate drink preoperative, early removal of chest tubes) is evaluated compared to conventional perioperative treatment (patient controlled analgesia, no carbohydrate drink preoperative) in patients with FEV1 < 70% of expected value or < 1.5L who… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiration Disorders
- What is being tested?
- Fast track lung surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2007to Oct 2008
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- resection of the lung
- FEV1 <70% of expected value or below 1.5L
- 18-80y
- given written informed consent
Who cannot join
- contraindication for epidural anesthesia
- prio ipsilateral thoracotomy
- chemotherapy <6 weeks prior to study enter
- existing pneumonia (fever, elevated WCC, elevated CRP)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Ulm
Ulm, 89075
Bernd M Muehling, M.D., +49-731-500 ext. 54055, bernd.muehling@uniklinik-ulm.de
Alexander Oberhuber, M.D., +49-731-500 ext. 54058, alexander.oberhuber@uniklinik-ulm.de
About this study
Official title: Prospective Randomized Controlled Trial to Reduce Morbidity and Mortality After Lung Surgery in Patients With FEV1 < 70% of Expected Value or < 1.5L
A fast track recovery program (thoracic epidural anesthesia, carbohydrate drink preoperative, early removal of chest tubes) is evaluated compared to conventional perioperative treatment (patient controlled analgesia, no carbohydrate drink preoperative) in patients with FEV1 < 70% of expected value or < 1.5L who undergo resections of the lung.
- Conditions
- Respiration Disorders
- Being tested
- Fast track lung surgery
- Keywords
- lung resection, reduced pulmonary function
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast track lung surgeryProcedure or surgery
fast track lung surgery: carbohydrate drink preoperatively, PCEA, early removal of chest tube conventional: no carbohydrate drink preoperatively, ICB+PCA, removal of chest tube depending upon chest x-ray
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | conventional perioperative management for lung surgery Receives: Procedure: Fast track lung surgery |
| 2 | Experimental | fast track management for lung surgery Receives: Procedure: Fast track lung surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary complications (air leak, atelectasis, pneumonia); lung function on pod 7; overall mortality
Measured: 1 year
Secondary outcomes (1)
duration of ICU treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2008 (estimated)
- Study completionOct 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration DisordersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University
- Investigators
- Bernd M Muehling, M.D., Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530491
- Sponsor's protocol ID
- BM 140/07
- Status last verified
- Sep 2007
- First submitted
- 13 Sep 2007
- Last updated
- 14 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial to Reduce Morbidity and Mortality After Lung Surgery in Patients With FEV1 < 70% of Expected Value or < 1.5L
- ClinicalTrials.gov ID
- NCT00530491
- Acronym / sponsor ID
- BM 140/07
- Conditions
- Respiration Disorders
- Keywords
- lung resection, reduced pulmonary function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- Heidelberg University
- Study start
- Sep 2007
- Primary completion
- Sep 2008 (estimated)
- Study completion
- Oct 2008 (estimated)
- First posted
- 17 Sep 2007 (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.
A fast track recovery program (thoracic epidural anesthesia, carbohydrate drink preoperative, early removal of chest tubes) is evaluated compared to conventional perioperative treatment (patient controlled analgesia, no carbohydrate drink preoperative) in patients with FEV1 < 70% of expected value or < 1.5L who undergo resections of the lung.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Fast track lung surgeryconventional perioperative management for lung surgery |
| 2 | Experimental | Procedure: Fast track lung surgeryfast track management for lung surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- resection of the lung
- FEV1 <70% of expected value or below 1.5L
- 18-80y
- given written informed consent
Key exclusion criteria (4 listed)
- contraindication for epidural anesthesia
- prio ipsilateral thoracotomy
- chemotherapy <6 weeks prior to study enter
- existing pneumonia (fever, elevated WCC, elevated CRP)
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 |
|---|---|---|
| Fast track lung surgeryfast track lung surgery: carbohydrate drink preoperatively, PCEA, early removal of chest tube conventional: no carbohydrate drink preoperatively, ICB+PCA, removal of chest tube depending upon chest x-ray | Procedure or surgery | 1, 2 |
Primary outcome
pulmonary complications (air leak, atelectasis, pneumonia); lung function on pod 7; overall mortality
Time frame: 1 year
1 secondary outcome
duration of ICU treatment
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2008.
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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.
Bernd M Muehling, M.D. study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast track lung surgery in people with Respiration Disorders, run by University of Ulm at 1 site 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 4 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: status not confirmed, as of the sponsor's last update on 14 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bernd M Muehling, M.D. (+49-731-500 ext. 54044, bernd.muehling@uniklinik-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary complications (air leak, atelectasis, pneumonia); lung function on pod 7; overall mortality (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2008; AzTrials last refreshed its copy on 6 Nov 2026.