Prospective, randomized controlled, single center study evaluating additional respiration therapy with a PEP trainer to prevent pneumonia in patients with higher neutropenic risk under chemotherapeutic treatment of an acute myeloic leukemia
Not Applicable
Recruiting
- Conditions
- C92J18Myeloid leukaemiaPneumonia, organism unspecified
- Registration Number
- DRKS00019842
- Lead Sponsor
- Vivantes Klinikum Neukölln - Hämatologie, Onkologie und Palliativmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
1. Patient with AML under first-line high dose chemotherapy treated as in-patient under curative intention (OR patients under high dose chemotherapy with consecutive autologous stem cell transplantation - extended additional study population) .
2. Informed consent
Exclusion Criteria
1. Patient with diagnosed pulmonary infection at study start.
2. Patient with known primary immunodeficiency or uncontrolled HIV infection (Patients with known HIV infection but controlled disease, normal CD4 count and undetectable HIV virus load can participate).
3. Patients with COPD GOLD III or IV or severe bronchial asthma.
4. Patients with known infectious pulmonary disease.
5. Patient unwilling or able to perform physio- and respiration therapy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Radiological confirmed pneumonia
- Secondary Outcome Measures
Name Time Method a) Severe clinical events (sepsis, admission to ICU, death)<br>b) Analysis of administered anti-infective drugs and time of treatment.<br>c) Number of hospital days