Long-Term Study On Home Spirometry After Lung Transplantation
- Conditions
- Lung TransplantationRejectionDeathBronchiolitis Obliterans
- Registration Number
- NCT00743171
- Lead Sponsor
- Hannover Medical School
- Brief Summary
Prospective cohort, mono-center study included electronic data of home spirometry (HS, lung function) of lung transplant recipients
- Detailed Description
Study period between 1/2/2000 and 31/12/2003 Follow-up until 31/12/2007
Patient will be stratified according to adherence to HS during the first 2 postoperative years Good adherent patient: patient performed ≥ 80% of predicted HS within 24 months Moderate adherent patient: patient performed ≥ 50% of predicted HS within 24 months Non-adherent patient: patient performed \< 50% of predicted HS within 24 months.
Primary outcome measure graft loss at end of follow-up
Secondary outcome measure number of acute rejections during follow-up number of hospitalisation during follow-up Incidence of bronchiolitis obliterans syndrome during follow-up
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 152
- Any type of lung transplant incl single, double, combined and re-do
- > 18 years of age
- LTx or HLTx ≥ 6mts post Tx
- Stable health condition at study entry (pt stays within home environment)
- Sufficient language skills for AMOS training
- Successful AMOS training
- Follow-up at our center (≥6 mts post LTx)
- Willingness to participate by informed consent
- Refused consent
- BOS diagnosis before study inclusion
- Malignancy before study inclusion
- Loss for follow-up (≤ 6 mts after study inclusion
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Graft loss 3 year
- Secondary Outcome Measures
Name Time Method BOS 3 year Number of acute rejections 3 year Number of hospitalizations 3 year
Trial Locations
- Locations (1)
Hannover Medical School
🇩🇪Hannover, Germany