Transnasal Insufflation (TNI) and Chronic Obstructive Pulmonary Disease (TNICOPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Nasal Insufflation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, TNI, PaCO2
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
Sites / Locations
- Helios Klinik Hagen Ambrock
Outcomes
Primary Outcome Measures
partial pressure of carbon dioxide (PaCO2) decrease
PaCO2 is measured before and after applying TNI, and a PaCO2 decrease is supposed to be assessed.
Secondary Outcome Measures
Breathing Frequency
Breathing Frequency is supposed to decrease under TNI treatment
Full Information
NCT ID
NCT01090544
First Posted
March 19, 2010
Last Updated
September 29, 2010
Sponsor
Helios Klinik Ambrock
1. Study Identification
Unique Protocol Identification Number
NCT01090544
Brief Title
Transnasal Insufflation (TNI) and Chronic Obstructive Pulmonary Disease
Acronym
TNICOPD
Official Title
Transnasal Insufflation for Patients With COPD GOLD IV and Hypercapnia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Helios Klinik Ambrock
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, TNI, PaCO2
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Nasal Insufflation
Other Intervention Name(s)
TNI 20 oxy
Intervention Description
Breathing therapy
Primary Outcome Measure Information:
Title
partial pressure of carbon dioxide (PaCO2) decrease
Description
PaCO2 is measured before and after applying TNI, and a PaCO2 decrease is supposed to be assessed.
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Breathing Frequency
Description
Breathing Frequency is supposed to decrease under TNI treatment
Time Frame
3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Nilius, MD
Organizational Affiliation
Helios Klinik Hagen Ambrock
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helios Klinik Hagen Ambrock
City
Hagen
State/Province
NRW
ZIP/Postal Code
58091
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Transnasal Insufflation (TNI) and Chronic Obstructive Pulmonary Disease
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