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

This study has been completed.
Sponsor:
Information provided by:
Helios Klinik Ambrock
ClinicalTrials.gov Identifier:
NCT01090544
First received: March 19, 2010
Last updated: September 29, 2010
Last verified: September 2010
  Purpose

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 Intervention
Chronic Obstructive Pulmonary Disease (COPD)
Device: Nasal Insufflation

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Helios Klinik Ambrock:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Breathing Frequency [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    Breathing Frequency is supposed to decrease under TNI treatment


Enrollment: 21
Study Start Date: December 2009
Study Completion Date: September 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Nasal Insufflation
    Breathing therapy
    Other Name: TNI 20 oxy
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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • serious acute diseases
  • hypercapnic decompensation pH < 7,30
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01090544

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

No publications provided

Responsible Party: Georg Nilius MD, Helios Klinik Hagen Ambrock
ClinicalTrials.gov Identifier: NCT01090544     History of Changes
Other Study ID Numbers: Helios TNI 2010
Study First Received: March 19, 2010
Last Updated: September 29, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Helios Klinik Ambrock:
COPD
TNI
PaCO2

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

ClinicalTrials.gov processed this record on July 23, 2014