Clinical Trial: Nocturnal Transnasal Insufflation (nTNI)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Nocturnal Transnasal Insufflation in Patients With COPD and Hypercapnia

Brief Summary:

On the basis of different studies the long term oxygen treatment is deemed to be routine treatment in patients suffering from chronic obstructive pulmonary disease (COPD) at appearance of hypoxaemia. Non invasive ventilation (NIV) is the treatment of choice in hypercapnic COPD patients with respiratory acidosis at acute respiratory decompensation. Several prospective randomized studies have shown a reduction of acute mortality as result. But everyday practice shows that COPD patients with chronic hypercapnia hardly accustom oneself to nocturnal ventilation. Reasons are not known yet, but substantial pulmonary overinflation or the appearance of depressions or rather anxiety disorders are possible causes. On the other hand patients may not notice any subjective improvement of symptoms and won't accept the burden of a tight fitting mask during the night. The aim of the present study is to determine the effect on gas exchange of a nocturnal transnasal application of an oxygen-enriched gaseous mixture via nasal cannula and the subjective acceptance. This is compared to a nocturnal transnasal application of oxygen alone in randomized order for at least 6 hours each night.

Thirty hypercapnic COPD GOLD IV patients (PCO2 > 50 mmHg) will be included. The two night Polysomnographies (PSG) will be evaluated with special attention to nasal flow measurements, breathing effort, oxygen saturation and an additional transcutaneous PCO2 measurement. At begin and end of each measurement night a capillary blood gas analysis is made.


Detailed Summary:
Sponsor: Institut für Pneumologie Hagen Ambrock eV

Current Primary Outcome: PCO2 decrease [ Time Frame: within 2 days ]

During the study nights the patients PCO2 value is measured transcutaneous as well as by capillary blood gas analyses (BGA) in the evening and in the morning. The differences in PCO2 values of the morning BGA will be compared, a PCO2 decrease is supposed to be assessed under TNI treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome: Changes of breathing pattern [ Time Frame: within 2 days ]

Changes of breathing pattern and breahing frequency will be recorded during the nights and means and course evaluated. Breathing Frequency is supposed to decrease under TNI treatment


Original Secondary Outcome: Same as current

Information By: Institut für Pneumologie Hagen Ambrock eV

Dates:
Date Received: November 3, 2011
Date Started: August 2011
Date Completion:
Last Updated: September 24, 2012
Last Verified: September 2012