Transnasal Insufflation (TNI) and Chronic Obstructive Pulmonary Disease

NCT ID: NCT01090544

Last Updated: 2010-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2010-09-30

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; TNI; PaCO2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Nasal Insufflation

Breathing therapy

Intervention Type: DEVICE

Other Intervention Names

TNI 20 oxy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helios Klinik Ambrock

OTHER

Sponsor Role: lead

Responsible Party

Helios Klinik Hagen Ambrock

Principal Investigators

Georg Nilius, MD

Role: PRINCIPAL_INVESTIGATOR

Helios Klinik Hagen Ambrock

Locations

Helios Klinik Hagen Ambrock

Hagen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

Helios TNI 2010

Identifier Type: -

Identifier Source: org_study_id