Clinical trial NCT01090544: Transnasal Insufflation (TNI) and Chronic Obstructive Pulmonary Disease
Official title: Transnasal Insufflation for Patients With COPD GOLD IV and Hypercapnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
TNI
PaCO2
Lead sponsor: Helios Klinik Ambrock
Sponsor class: OTHER
First posted: 2010-03-22
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* COPD GOLD IV
* PCO2 \> 50 mmHg
* competent patients
* stable respiratory situation

Exclusion Criteria:

* serious acute diseases
* hypercapnic decompensation pH \< 7,30

Primary outcomes:
measure: partial pressure of carbon dioxide (PaCO2) decrease
timeFrame: 3 hours
Secondary outcomes:
measure: Breathing Frequency
timeFrame: 3 hours
Other outcomes:
Locations:
city: Hagen
country: Germany
facility: Helios Klinik Hagen Ambrock
state: NRW
Study officials:
affiliation: Helios Klinik Hagen Ambrock
name: Georg Nilius, MD
role: PRINCIPAL_INVESTIGATOR
References: