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Completed

NCT Number: NCT01090544

Transnasal Insufflation (TNI) and Chronic Obstructive Pulmonary Disease

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helios Klinik Hagen Ambrock

Hagen, North Rhine-Westphalia, 58091, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Nasal Insufflation

Device

Breathing therapy

Other names: TNI 20 oxy

Primary outcomes

  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 outcomes

  1. Breathing Frequency

    Time frame: 3 hours

    Breathing Frequency is supposed to decrease under TNI treatment

Sponsors and collaborators

Lead sponsor

Helios Klinik Ambrock

Other

Registry information

Official study title

Transnasal Insufflation for Patients With COPD GOLD IV and Hypercapnia

Acronym: TNICOPD

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 22, 2010
Registry last updated
Sep 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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