Transnasal Insufflation (TNI) and Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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The purpose of this study is to determine wether transnasal insufflation as an alternate form of breathing support for COPD patients will lead to improvement of their medical condition.

Detailed Description
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Chronic obstructive pulmonary disease (COPD) is a slowly proceeding lung disease which basic pathophysiologic mechanisms are only partly understood so far and which is difficult to access with a pharmacological or sundry approach besides smoking cessation. Average life expectancy is clearly limited especially in advanced stages with respiratory insufficiency . Based on different smaller surveys long-term oxygen treatment is classified to be the routine in COPD treatment when patients develop hypoxemia. The primary application of non-invasive ventilation Routine is the treatment for COPD patients with acute respiratory decompensation and developing hypoxemia and respiratory acidosis, because it reduces the acute mortality as various prospective randomized studies showed. On the other side there are no distinct informations and data about the initiation of a nocturnal positive pressure breathing therapy when chronic hypercapnia appear in progression of COPD. Nocturnal positive pressure therapy appliqued with a mask can be assumed to be the routine treatment for neuromuscular and restrictive thorax diseases, because nocturnal ventilation results in a distinct increase of life expectancy. In contrast data about positive pressure therapy at COPD are inconsistent and initiation of nocturnal breathing therapy is practised in many places, but is scientifically not confirmed yet. It is known from various other studies with other patient collectives with nocturnal positive pressure therapy, like patients with obstructive sleep apnoea syndrome, that only 50 to 70% of those patients are using their therapy constantly. Daily practice shows that patients with chronic hypercapnia based on COPD are even harder to accustom oneself to a nocturnal breathing therapy than patients with restrictive lung diseases or patients with obstructive sleep apnoea syndrome. Reasons for that are not known, but maybe the significant lung distension or increased appearance of depressive or anxiety disorders of COPD patients are responsible for that. Perhaps patients do not feel a subjective improvement of their medical condition and don't accept a tight closing mask at nights. As a result an alternate form of breathing support would be desirable.

Official Title
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Transnasal Insufflation for Patients With COPD GOLD IV and Hypercapnia

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Device: Nasal Insufflation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD GOLD IV PCO2 > 50 mmHg competent patients stable respiratory situation Exclusion Criteria: serious acute diseases hypercapnic decompensation pH < 7,30

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Nasal Insufflation|Breathing therapy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| partial pressure of carbon dioxide (PaCO2) decrease | PaCO2 is measured before and after applying TNI, and a PaCO2 decrease is supposed to be assessed. | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breathing Frequency | Breathing Frequency is supposed to decrease under TNI treatment | 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, TNI, PaCO2