The purpose of this trial ist to investigate the difference of the efficacy of two systems for breath support in patients with COPD.
The trial consists of 12 weeks of therapy that is divided into two sections. In the first 6-week section patients receive treatment with either TNI or BiPAP and in the second 6-week section treatment is changed. The starting therapy is allocated to the patients via randomisation and should be started directly after the baseline visit. The treatment and the follow-up period end with the second visit after the second treatment section and the patient decides which device he/she wants to use further.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Klinik Donaustauf, Zentrum für Pneumologie
Donaustauf, Bavaria, Germany
Asklepios Fachkliniken München-Gauting, Klinik für Intensivmedizin und Langzeitbeatmung
Muenchen-Gauting, Bavaria, Germany
difference in capillary CO2 carbon dioxide
The primary endpoint is the difference of the capillary pC02 between the treatment with nasal high-flow compared with the baseline value.
Time frame: Baseline, 6 weeks, 12 weeks
difference in absolute change of capillary pCO2 (partial pressure of carbon dioxide ) compared with baseline
Time frame: Baseline, 6 weeks, 12 weeks
frequency of occurrence of normocapnia after intervention
Normocapnia is therefore defined as capillary pCO2 \<= 45 mmHg
Time frame: Baseline, 6 weeks, 12 weeks
difference of the relative and absolute change of capillary pCO2 compared with baseline
Time frame: Baseline, 6 weeks, 12 weeks
difference of the absolute change of SaO2 (arterial oxygen saturation) compared with baseline
Time frame: Baseline, 6 weeks, 12 weeks
difference of the absolute and relative change of base excess compared with baseline
Time frame: Baseline, 6 weeks, 12 weeks
difference of the values of base excess after treatment with nHF (nasal high-flow) and of base excess after treatment with BiPAP
Time frame: baseline, 6 weeks, 12 weeks
difference of the absolute change of HCO3- (hydrogen carbonate / bicarbonate) compared with baseline
Time frame: baseline, 6 weeks, 12 weeks
difference of HCO3- after treatment with nHF and of HC03- after treatment with BiPAP
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Klinikum Nürnberg Nord, Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin
Nuremberg, Bavaria, Germany
RoMed Klinikum Rosenheim, Medizinische Klinik III, Pneumologie
Rosenheim, Bavaria, Germany
Marienkrankenhaus Kassel gGmbH, Medizinische Klinik / Pneumologie
Kassel, Hesse, Germany
Evangelisches Krankenhaus Göttingen-Weende gGmbH, Abteilung für Pneumologie
Bovenden, Lower Saxony, Germany
Fachkrankenhaus Kloster Grafschaft GmbH, Schlafmedizin & häusliche Beatmung
Schmallenberg, North Rhine-Westphalia, Germany
Diakonisches Werk Bethanien e.V, Klinik für Pneumologie
Solingen, North Rhine-Westphalia, Germany
Universitätsklinikum Leipzig, Department für Innere Medizin, Neurologie und Dermatologie
Leipzig, Saxony, Germany
Zentralklinik Bad Berka GmbH, Klinik für Pneumologie
Bad Berka, Thuringia, Germany
...and 4 more locations
Time frame: baseline, 6 weeks, 12 weeks
difference of P0,1 after treatment with nHF and of P0,1 after treatment with BiPAP
Time frame: baseline, 6 weeks, 12 weeks
difference of PImax after treatment with nHF and of PImax (maximal inspiratory pressure) after treatment with BiPAP
Time frame: baseline, 6 weeks, 12 weeks
difference of P0,1/PImax after treatment with nHF and of P0,1/PImax after treatment with BiPAP
Time frame: baseline, 6 weeks, 12 weeks
difference of the absolute change of the results of the 6-minutes walking test compared with baseline
Time frame: baseline, 6 weeks, 12 weeks
difference of the absolute change of the disease-specific quality of life compared to baseline
Quality of life is measured by SGQR (The St George's Respiratory Questionnaire), SRI (Severe Respiratory Insufficiency Questionnaire), a VAS referring to the general health status and the Borg-Scale (CR 10)
Time frame: baseline, 6 weeks, 12 weeks
frequency of occurrence and type of adverse events under trial therapy (both arms)
Time frame: baseline, 6 weeks, 12 weeks
difference of the values of user-friendliness of both devices
Time frame: baseline, 6 weeks, 12 weeks
difference of the time both devices were used
Time frame: baseline, 6 weeks, 12 weeks