Prospective Trial to Reduce Morbidity and Mortality After Lung Surgery in Patients With Reduced Pulmonary Capacity
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by University of Ulm.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Ulm
Collaborator:
University of Heidelberg
Information provided by:
University of Ulm
ClinicalTrials.gov Identifier:
NCT00530491
First received: September 13, 2007
Last updated: February 1, 2008
Last verified: September 2007
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 13, 2007 | ||||||||
| Last Updated Date | February 1, 2008 | ||||||||
| Start Date ICMJE | September 2007 | ||||||||
| Estimated Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
pulmonary complications (air leak, atelectasis, pneumonia); lung function on pod 7; overall mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE |
pulmonary complications (air leak, atelectasis, pneumonia); lung function on pod 7; overall mortality [ Time Frame: 1 year ] | ||||||||
| Change History | Complete list of historical versions of study NCT00530491 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
duration of ICU treatment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
duration of ICU treatment [ Time Frame: 1 year ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Prospective Trial to Reduce Morbidity and Mortality After Lung Surgery in Patients With Reduced Pulmonary Capacity | ||||||||
| Official Title ICMJE | Prospective Randomized Controlled Trial to Reduce Morbidity and Mortality After Lung Surgery in Patients With FEV1 < 70% of Expected Value or < 1.5L | ||||||||
| Brief 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 undergo resections of the lung. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Respiration Disorders | ||||||||
| Intervention ICMJE | Procedure: Fast track lung 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 |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 90 | ||||||||
| Estimated Completion Date | October 2008 | ||||||||
| Estimated Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00530491 | ||||||||
| Other Study ID Numbers ICMJE | BM 140/07 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Bernd Muehling, M.D., Dep. of Thoracic and Vascular Surgery, University of Ulm , Germany | ||||||||
| Study Sponsor ICMJE | University of Ulm | ||||||||
| Collaborators ICMJE | University of Heidelberg | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Ulm | ||||||||
| Verification Date | September 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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