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| Name | Class |
|---|---|
| TNI Medical AG | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BiPAP breathing support | Active Comparator | BiPAP is used over a period of 6 weeks (outpatient) |
|
| nHF / TNI breathing support | Experimental | nasal high-flow is used over a period of 6 weeks (outpatient) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nHF | Device | nasal high-flow is used over a period of 6 weeks (outpatient) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| difference in absolute change of capillary pCO2 (partial pressure of carbon dioxide ) compared with baseline | Baseline, 6 weeks, 12 weeks | |
| frequency of occurrence of normocapnia after intervention | Normocapnia is therefore defined as capillary pCO2 <= 45 mmHg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Braeunlich, Dr. | Medical Faculty University Leipzig | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik Donaustauf, Zentrum für Pneumologie | Donaustauf | Bavaria | 93093 | Germany | ||
| Asklepios Fachkliniken München-Gauting, Klinik für Intensivmedizin und Langzeitbeatmung |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| BiPAP | Device | BiPAP is used over a period of 6 weeks (outpatient) |
|
| Baseline, 6 weeks, 12 weeks |
| difference of the relative and absolute change of capillary pCO2 compared with baseline | Baseline, 6 weeks, 12 weeks |
| difference of the absolute change of SaO2 (arterial oxygen saturation) compared with baseline | Baseline, 6 weeks, 12 weeks |
| difference of the absolute and relative change of base excess compared with baseline | 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 | baseline, 6 weeks, 12 weeks |
| difference of the absolute change of HCO3- (hydrogen carbonate / bicarbonate) compared with baseline | baseline, 6 weeks, 12 weeks |
| difference of HCO3- after treatment with nHF and of HC03- after treatment with BiPAP | baseline, 6 weeks, 12 weeks |
| difference of P0,1 after treatment with nHF and of P0,1 after treatment with BiPAP | baseline, 6 weeks, 12 weeks |
| difference of PImax after treatment with nHF and of PImax (maximal inspiratory pressure) after treatment with BiPAP | baseline, 6 weeks, 12 weeks |
| difference of P0,1/PImax after treatment with nHF and of P0,1/PImax after treatment with BiPAP | baseline, 6 weeks, 12 weeks |
| difference of the absolute change of the results of the 6-minutes walking test compared with baseline | 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) | baseline, 6 weeks, 12 weeks |
| frequency of occurrence and type of adverse events under trial therapy (both arms) | baseline, 6 weeks, 12 weeks |
| difference of the values of user-friendliness of both devices | baseline, 6 weeks, 12 weeks |
| difference of the time both devices were used | baseline, 6 weeks, 12 weeks |
| Muenchen-Gauting |
| Bavaria |
| 82131 |
| Germany |
| Klinikum Nürnberg Nord, Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin | Nuremberg | Bavaria | 90419 | Germany |
| RoMed Klinikum Rosenheim, Medizinische Klinik III, Pneumologie | Rosenheim | Bavaria | 83022 | Germany |
| Marienkrankenhaus Kassel gGmbH, Medizinische Klinik / Pneumologie | Kassel | Hesse | 34127 | Germany |
| Evangelisches Krankenhaus Göttingen-Weende gGmbH, Abteilung für Pneumologie | Bovenden | Lower Saxony | 37120 | Germany |
| Fachkrankenhaus Kloster Grafschaft GmbH, Schlafmedizin & häusliche Beatmung | Schmallenberg | North Rhine-Westphalia | 57392 | Germany |
| Diakonisches Werk Bethanien e.V, Klinik für Pneumologie | Solingen | North Rhine-Westphalia | 42699 | Germany |
| Universitätsklinikum Leipzig, Department für Innere Medizin, Neurologie und Dermatologie | Leipzig | Saxony | 04107 | Germany |
| Zentralklinik Bad Berka GmbH, Klinik für Pneumologie | Bad Berka | Thuringia | 99437 | Germany |
| Evangelisches Krankenhaus Bergisch Gladbach, Pneumologie | Bergisch Gladbach | 51465 | Germany |
| HELIOS Klinikum Emil von Behring, Klinik für Pneumologie | Berlin | 14165 | Germany |
| Asklepios Klinik Harburg, Lungenheilkunde (Pneumologie) im Thoraxzentrum, Sektion Pneumologische Intensiv- u. Beatmungsmedizin | Hamburg | 21079 | Germany |
| Waldburg-Zeil Kliniken, Fachkliniken Wangen, Lungenzentrum Süd-West | Wangen | 88239 | Germany |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |