Effectiveness of TNI vs. BiPAP in Chronic Global Insufficiency in COPD Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of TNI (Nasal High-flow) vs. BiPAP (Biphasic Positive Airway Pressure) in Chronic Global Insufficiency in COPD (Chronic Obstructive Pulmonary Disease) Patients

Conditions
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COPD Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: nHF
* Device: BiPAP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BiPAP breathing support<br>BiPAP is used over a period of 6 weeks (outpatient) | Device: nHF<br>* nasal high-flow is used over a period of 6 weeks (outpatient)<br>* Other names: nasal high-flow;Device: BiPAP<br>* BiPAP is used over a period of 6 weeks (outpatient)<br>|
| Experimental: nHF / TNI breathing support<br>nasal high-flow is used over a period of 6 weeks (outpatient) | Device: nHF<br>* nasal high-flow is used over a period of 6 weeks (outpatient)<br>* Other names: nasal high-flow;Device: BiPAP<br>* BiPAP is used over a period of 6 weeks (outpatient)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, nHF, BiPAP