J18 N30
Conditions
Interventions
Group 1: Intervention group receives the "Standard of care":
- daily vital signs measurement
- daily blood samples
- ECG
- chest X-ray
In addition, a non-invasive wireless monitoring device (photop
Sponsors
Universitätsklinikum Düsseldorf
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with acute leukemia, myelodysplastic or myeloproliferative syndromes, aggressive lymphoproliferative disorders or germ cell tumors requiring treatment with intensive chemotherapy, allogenic/ autologous blood stem cell transplantation • Application of an intensive (radio-) chemotherapy protocol which is known to usually induce hematotoxicity CTC = III for a minimum of 7 days (ICE, DA, HAM, FluBu, BuCy, FluTreo, FluTBI, B-ALL, GMALL Kons I, ect.) • Age 18 years and able to understand design and objectives of the trial • Signed written informed consent and data safety agreement before any trial-related activities • Willingness to continuously wear the CVSM device throughout the evaluation period
Exclusion criteria
Exclusion criteria: • Medical or mental conditions (e.g. dementia) impairing the ability to continuously wear the CVSM device throughout the evaluation period • Active implants (e.g. pacemaker) • Tattoo on upper arm • Skin disease or defects on upper arm • Allergic to device or its components (e.g. synthetic fabrics) • Conditions which preclude wearing a device on upper arm (e.g. Shunt, active bleeding) • History of non-functional Hemoglobin (sickle-cell anemia, recent carbon monoxide intoxication) • Mental incapacity or language barriers which preclude adequate understanding or cooperation, known or suspected not to comply with trial directives or not to be reliable or trustworthy, or subject who in the opinion of the investigator should not participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Feasibility of CVSM device usage under hospital conditions assessed by ratio of CVSM data compared to the time the device was worn, occurred technical issues and assessment of workload by nursing staff | — |
Secondary
| Measure | Time frame |
|---|---|
| • Identifying algorithms to detect SCC in CVSM data of patients receiving intensive chemotherapy or allogenic/ autologous blood stem cell transplantation for the treatment of aggressive hematologic malignancies. • To evaluate the sensitivity and specificity of the identified algorithms with a promising performance to detect SCC in CVSM data in comparison to the standard of care. The clinical documentation of each subject will be reviewed to identify time and kind of serious clinical complication. • Time from detection of a SCC by the Everion device to detection by regular monitoring performed by hospital staff or regular blood tests • Questionnaire to assess Quality of life associated with wearing a CVSM device | — |
Countries
Germany
Contacts
Public ContactPauline Auffermann
Universitätsklinikum Düsseldorf
Outcome results
None listed