Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Efficacy and Physiology of Nasal High Flow Therapy (AIRVO2™, Fisher&Paykel) in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Hypercapnic Respiratory Failure
The effects of a nasal high-flow (NHF) therapy in patients with chronic obstructive
hypercapnic respiratory failure are still not sufficiently known yet.
The aim of this study is a step-by-step generation of physiological data about gas exchange
and respiration under high flow therapy using a nasal cannula with an AIRVO 2 device to
provide NHF, leading to an analysis of the effects of high flow on PCO2 levels, exercise
capacity, quality of life and gas exchange in a long term home treatment compared to a
standard low flow long term oxygen therapy (LOT).
Hypothesis: NHF and LOT therapy show differences in measured mean overnight transcutaneous
carbon dioxide partial pressure (PCO2) after four weeks of treatment.
Stage 1: Respiratory Physiology. Aim of this Stage is to investigate the effects of nasal
High Flow (NHF) therapy in patients in progressed stages of COPD, by measuring physiologic
parameters like tidal volume, breathing frequency and expiratory PCO2 concentration.
Stage 2: Efficacy of short term NHF. Aim of this Stage is to evaluate the efficacy of two
flow rates (20 L/min and 35 L/min) regarding alveolar ventilation in overnight therapy. For
this reason, patients will have two PSG sleep studies during their hospital stay, under 20
L/min and 35 L/min NHF therapy in randomized order.
Stage 3: Home Care monitoring. Aim of this Stage is to compare long term influences of NHF
and LOT on PCO2 levels randomised crossover, 4 weeks each treatment.
Stage 4: Long Term Home Care monitoring . Aim of this stage is the long term follow up (12
month) of patients to examine the compliance of a sufficient NHF therapy. Patients will
retain the NHF therapy if they are responders (PCO2 improvement in stage 3 of at least 2 mmHG
with NHF versus LOT) and willing and able to use NHF and a patient log.
All patients will be monitored for the next 12 month. After 6 month there will be a control
phone call.
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