Neurological diseases (e. g. neuromuscular diseases, disorders of the respiratory center) and lung damages
Conditions
Interventions
Group 1: The observation center collects the corresponding data according to its clinical routine and patient population to guarentee the generalizeability of data analysis results that should not onl
acquisition of efficacy/ clinical benefit, number of attempts for therapy setting with/ switch to LUISA, performance, adverse effects
If patient´s condition allows:
Step 2
Home therapy with LUISA, du
acquisition of efficacy/ clinical benefit, performance, adverse effects
As far as possible parameters are quantitatively acquisited and documented. Evaluation of symptomatology in clinical as well as
Sponsors
Löwenstein Medical Technology GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Clinical ventilation (e. g. because of acute respiratory failure) with a clinical ventilator (different from LUISA) Or Change of ventilator with an clinical application equivalent to LUISA as part of therapy control Or Primary ventilation therapy setting Indication for subsequent home ventilation according to corresponding guidline
Exclusion criteria
Exclusion criteria: Data for primary variable are missing, incomplete or not evaluable because of poor quality The quality management detects differences in the data sets compared to source data that can´t be settled. Presece of contra-indication for ventilation Missing or cancelled informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acquisition of efficacy/ clinical benefit of LUISA during primary therapy setting or switch from a clinical/ previously used home ventilator to LUISA; evaluation of efficacy/ clinical benefit by physician based on symptomatology, blood gases and patient´s acceptance | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical stage: Evaluation of performance during primary setting with or device change to LUISA: 1.) by physician based on his/ her estimation as part of clinical routine (especially pressure levels, respiratory rate, synchronicity, handling, where approriate: automatic control mode); 2.) by manufacturer based on analysis of device data (with focus on pressure stability, synchronicity, performance conforming to specification, where approriate: automatic control mode); Optional: evaluation of efficacy and performance of LUISA (especially on pressure stability, synchronicity, performance conforming to specification, where approriate: automatic control mode) based on additional clinical data, e. g. transcutaneous CO2 measurement, monitoring of vital function, poly(somno)graphy, etc. Home stage: Acquisition of performance/ efficacy/ clinical benefit of LUISA in the home environment 1.) by care taker: evaluation of efficacy and clinical benefit based on symptomatology and patient`s acceptance; evaluation of performance (especially handling and where approriate: automatic control) based on his/ her estimation as part of clinical routine; 2.) by manufacturer: evaluation of performance (with focus on pressure stability, synchronicity, performance conforming to specification, where appropriate: automatic control mode) based on analysis of device data; Optional: evaluation of efficacy and performance of LUISA (especially on pressure stability, synchronicity, performance conforming to specification, where approriate: automatic control mode) based on additional clinical, e. g. blood gases, pulse oximetry, etc.; acquisition of possible adverse effects; evaluation of benefit-risk-profile of LUISA | — |
Countries
Germany
Contacts
Public ContactJörg Grosse-Onnebrink
Universitätsklinikum Münster
Outcome results
None listed