Transnasal Insufflation (TNI) and Chronic Obstructive Pulmonary Disease (TNICOPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01090544
Recruitment Status : Completed
First Posted : March 22, 2010
Last Update Posted : September 30, 2010
Information provided by:
Helios Klinik Ambrock

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Device: Nasal Insufflation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transnasal Insufflation for Patients With COPD GOLD IV and Hypercapnia
Study Start Date : December 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : September 2010

Intervention Details:
    Device: Nasal Insufflation
    Breathing therapy
    Other Name: TNI 20 oxy

Primary Outcome Measures :
  1. partial pressure of carbon dioxide (PaCO2) decrease [ Time Frame: 3 hours ]
    PaCO2 is measured before and after applying TNI, and a PaCO2 decrease is supposed to be assessed.

Secondary Outcome Measures :
  1. Breathing Frequency [ Time Frame: 3 hours ]
    Breathing Frequency is supposed to decrease under TNI treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • PCO2 > 50 mmHg
  • competent patients
  • stable respiratory situation

Exclusion Criteria:

  • serious acute diseases
  • hypercapnic decompensation pH < 7,30

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01090544

Helios Klinik Hagen Ambrock
Hagen, NRW, Germany, 58091
Sponsors and Collaborators
Helios Klinik Ambrock
Principal Investigator: Georg Nilius, MD Helios Klinik Hagen Ambrock

Responsible Party: Georg Nilius MD, Helios Klinik Hagen Ambrock Identifier: NCT01090544     History of Changes
Other Study ID Numbers: Helios TNI 2010
First Posted: March 22, 2010    Key Record Dates
Last Update Posted: September 30, 2010
Last Verified: September 2010

Keywords provided by Helios Klinik Ambrock:

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases