Continuous vital sign monitoring (CVSM) with a mobile device in patients receiving intensive chemotherapy or allogenic/ autologous blood stemcell transplantation for the treatment of aggressive hematologic malignancies to identify algorithms that detect serious clinical complications
- Conditions
- J18N30Pneumonia, organism unspecifiedCystitis
- Registration Number
- DRKS00014782
- Lead Sponsor
- niversitätsklinikum Düsseldorf
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 79
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
• 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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • 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 Outcome Measures
Name Time Method • 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.<br>• To evaluate the sensitivity and specificity of the identified algorithms with a promising<br>performance to detect SCC in CVSM data in comparison to the standard of care. The<br>clinical documentation of each subject will be reviewed to identify time and kind of serious clinical complication.<br>• Time from detection of a SCC by the Everion device to detection by regular monitoring performed by hospital staff or regular blood tests<br>• Questionnaire to assess Quality of life associated with wearing a CVSM device