Clinical trial NCT02007772: Effectiveness of TNI vs. BiPAP in Chronic Global Insufficiency in COPD Patients
Official title: Effectiveness of TNI (Nasal High-flow) vs. BiPAP (Biphasic Positive Airway Pressure) in Chronic Global Insufficiency in COPD (Chronic Obstructive Pulmonary Disease) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD Chronic Obstructive Pulmonary Disease
Keywords: COPD, nHF, BiPAP
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: TNI Medical AG
First posted: 2013-12-11
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this trial ist to investigate the difference of the efficacy of two systems for breath support in patients with COPD.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* presence of COPD with chronic respiratory global insufficiency
* chronic day-hypercapnia with pCO2 \>= 50 mmHg and typical symptoms of ventilatory insufficiency OR patients with exacerbation (after abate of acute symptomatology) with documented hypercapnia \>= 50 mmHG on preliminary findings
* age 18 or older
* the patient or caretaker must be able to operate the device after a specific training
* patient must be willing to use the nHF-/BiPAP-device for the whole trial period for at least 5 hours/day
* patient must be able to answer the questionnaires
* written informed consent is obtained

Exclusion Criteria:

* presence of acute respiratory insufficiency
* exacerbation of type I or II in the last 4 weeks
* conservative therapy including long-term oxygen therapy according to GOLD update 2011 is not exhausted
* previous treatment with NIV (non-invasive ventilation) in the last 14 days
* clinical instability or acute illness (e.g. acute myocardial infarction, tachycardial atrial fibrillation)
* signs of cardial decompensation (e.g. edema in the lower limbs, pleural effusion)
* other serious concomitant diseases, the assessment of eligibility is at the discretion of the investigator
* contraindications for NIV
* anamnestic suspicion or proven obstructive sleep apnea (OSA)
* relevant systemic infections, assessment of eligibility is at the discretion of the investigator
* BMI \> 30
* other additional pulmonary diseases of other genesis or diseases that affect breathing (e.g. mucoviscidosis, scoliosis, muscular diseases)
* lack of compliance
* participation in other interventional trials at the same time
* pregnant or nursing women
* fertile female patients without effective contraceptive measures during trial participation

Primary outcomes:
measure: difference in capillary CO2 carbon dioxide
timeFrame: Baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: difference in absolute change of capillary pCO2 (partial pressure of carbon dioxide ) compared with baseline
timeFrame: Baseline, 6 weeks, 12 weeks
measure: frequency of occurrence of normocapnia after intervention
timeFrame: Baseline, 6 weeks, 12 weeks
measure: difference of the relative and absolute change of capillary pCO2 compared with baseline
timeFrame: Baseline, 6 weeks, 12 weeks
measure: difference of the absolute change of SaO2 (arterial oxygen saturation) compared with baseline
timeFrame: Baseline, 6 weeks, 12 weeks
measure: difference of the absolute and relative change of base excess compared with baseline
timeFrame: Baseline, 6 weeks, 12 weeks
measure: difference of the values of base excess after treatment with nHF (nasal high-flow) and of base excess after treatment with BiPAP
timeFrame: baseline, 6 weeks, 12 weeks
measure: difference of the absolute change of HCO3- (hydrogen carbonate / bicarbonate) compared with baseline
timeFrame: baseline, 6 weeks, 12 weeks
measure: difference of HCO3- after treatment with nHF and of HC03- after treatment with BiPAP
timeFrame: baseline, 6 weeks, 12 weeks
measure: difference of P0,1 after treatment with nHF and of P0,1 after treatment with BiPAP
timeFrame: baseline, 6 weeks, 12 weeks
measure: difference of PImax after treatment with nHF and of PImax (maximal inspiratory pressure) after treatment with BiPAP
timeFrame: baseline, 6 weeks, 12 weeks
measure: difference of P0,1/PImax after treatment with nHF and of P0,1/PImax after treatment with BiPAP
timeFrame: baseline, 6 weeks, 12 weeks
measure: difference of the absolute change of the results of the 6-minutes walking test compared with baseline
timeFrame: baseline, 6 weeks, 12 weeks
measure: difference of the absolute change of the disease-specific quality of life compared to baseline
timeFrame: baseline, 6 weeks, 12 weeks
measure: frequency of occurrence and type of adverse events under trial therapy (both arms)
timeFrame: baseline, 6 weeks, 12 weeks
measure: difference of the values of user-friendliness of both devices
timeFrame: baseline, 6 weeks, 12 weeks
measure: difference of the time both devices were used
timeFrame: baseline, 6 weeks, 12 weeks
Other outcomes:
Locations:
city: Donaustauf
country: Germany
facility: Klinik Donaustauf, Zentrum für Pneumologie
state: Bayern
city: Muenchen-Gauting
country: Germany
facility: Asklepios Fachkliniken München-Gauting, Klinik für Intensivmedizin und Langzeitbeatmung
state: Bayern
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Nord, Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin
state: Bayern
city: Rosenheim
country: Germany
facility: RoMed Klinikum Rosenheim, Medizinische Klinik III, Pneumologie
state: Bayern
city: Kassel
country: Germany
facility: Marienkrankenhaus Kassel gGmbH, Medizinische Klinik / Pneumologie
state: Hessen
city: Bovenden
country: Germany
facility: Evangelisches Krankenhaus Göttingen-Weende gGmbH, Abteilung für Pneumologie
state: Niedersachsen
city: Schmallenberg
country: Germany
facility: Fachkrankenhaus Kloster Grafschaft GmbH, Schlafmedizin & häusliche Beatmung
state: Nordrhein-Westfalen
city: Solingen
country: Germany
facility: Diakonisches Werk Bethanien e.V, Klinik für Pneumologie
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig, Department für Innere Medizin, Neurologie und Dermatologie
state: Sachsen
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH, Klinik für Pneumologie
state: Thueringen
city: Bergisch Gladbach
country: Germany
facility: Evangelisches Krankenhaus Bergisch Gladbach, Pneumologie
city: Berlin
country: Germany
facility: HELIOS Klinikum Emil von Behring, Klinik für Pneumologie
city: Hamburg
country: Germany
facility: Asklepios Klinik Harburg, Lungenheilkunde (Pneumologie) im Thoraxzentrum, Sektion Pneumologische Intensiv- u. Beatmungsmedizin
city: Wangen im Allgäu
country: Germany
facility: Waldburg-Zeil Kliniken, Fachkliniken Wangen, Lungenzentrum Süd-West
Study officials:
affiliation: Medical Faculty University Leipzig
name: Jens Braeunlich, Dr.
role: STUDY_CHAIR
References: