Transnasal Insufflation (TNI) and Chronic Obstructive Pulmonary Disease (TNICOPD)
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Transnasal Insufflation for Patients With COPD GOLD IV and Hypercapnia|
- partial pressure of carbon dioxide (PaCO2) decrease [ Time Frame: 3 hours ] [ Designated as safety issue: No ]PaCO2 is measured before and after applying TNI, and a PaCO2 decrease is supposed to be assessed.
- Breathing Frequency [ Time Frame: 3 hours ] [ Designated as safety issue: No ]Breathing Frequency is supposed to decrease under TNI treatment
|Study Start Date:||December 2009|
|Study Completion Date:||September 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Device: Nasal Insufflation
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01090544
|Helios Klinik Hagen Ambrock|
|Hagen, NRW, Germany, 58091|
|Principal Investigator:||Georg Nilius, MD||Helios Klinik Hagen Ambrock|