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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

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 - NeutroRespCare

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00019842
Enrollment
100
Registered
2019-11-25
Start date
2019-05-10
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C92 J18

Interventions

Group 1: Physiotherapeutic standard therapy by local standard with additional respiration therapy with the PEP-trainer Mediflo duo (3 times daily 10 expirations) Group 2: Physiotherapeutic standard th

Sponsors

Vivantes Klinikum Neukölln - Hämatologie, Onkologie und Palliativmedizin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Radiological confirmed pneumonia

Secondary

MeasureTime frame
a) Severe clinical events (sepsis, admission to ICU, death) b) Analysis of administered anti-infective drugs and time of treatment. c) Number of hospital days

Countries

Germany

Contacts

Public ContactTil Kiderlen

Vivantes Klinikum Neukölln - Hämatologie, Onkologie und Palliativmedizin

tilramon.kiderlen@vivantes.de+49-30-130142251

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026