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

Transnasal Insufflation for Patients With COPD GOLD IV and Hypercapnia

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Device: Nasal Insufflation

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
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Hagen, NRW, Germany, 58091
      • Helios Klinik Hagen Ambrock

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
partial pressure of carbon dioxide (PaCO2) decrease	PaCO2 is measured before and after applying TNI, and a PaCO2 decrease is supposed to be assessed.	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breathing Frequency	Breathing Frequency is supposed to decrease under TNI treatment	3 hours

Collaborators and Investigators

• Sponsor: Helios Klinik Ambrock
• Investigators: Principal Investigator: Georg Nilius, MD, Helios Klinik Hagen Ambrock

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: March 19, 2010
• First Submitted That Met QC Criteria: March 19, 2010
• First Posted (Estimate): March 22, 2010

Study Record Updates

• Last Update Posted (Estimate): September 30, 2010
• Last Update Submitted That Met QC Criteria: September 29, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: COPD; TNI; PaCO2
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: Helios TNI 2010