Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2014-04-30
2018-11-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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nasal High Flow and Oxygen
overnight nasal High Flow (NHF) therapy+ individually titrated supplemental oxygen (2-6 L/min),total 35 L/min, 4 weeks at home
NHF therapy
AIRVO 2 device therapy is either a humidifier with integrated flow generator that delivers warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces. Flow rates up to 60 L/min are available to the user, depending on the patient interface and mode of operation.In this study, flow rates of 20 L/min and 35 L/min will be compared.
Long term Oxygen Therapy (LOT)
Oxygen will individually be added to NHF in order to achieve stable oxygen saturation by pulse oximetry (SpO2) values of 88% to 92%.
Long term Oxygen Therapy (LOT)
individually titrated supplemental oxygen (2-6 L/min), 4 weeks at home
Long term Oxygen Therapy (LOT)
Oxygen will individually be added to NHF in order to achieve stable oxygen saturation by pulse oximetry (SpO2) values of 88% to 92%.
Interventions
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NHF therapy
AIRVO 2 device therapy is either a humidifier with integrated flow generator that delivers warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces. Flow rates up to 60 L/min are available to the user, depending on the patient interface and mode of operation.In this study, flow rates of 20 L/min and 35 L/min will be compared.
Long term Oxygen Therapy (LOT)
Oxygen will individually be added to NHF in order to achieve stable oxygen saturation by pulse oximetry (SpO2) values of 88% to 92%.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male and female
* COPD patients with chronic respiratory insufficiency (pH \>7.35 and PCO2 \> 50mmHg)
* Stable respiratory situation
Exclusion Criteria
* Pregnancy or nursing period
* Participation in another clinical trial within the last 4 weeks
* Drug abuse
* Incapable of giving consent
* Known obstructive sleep apnea syndrome (OSA) (AHI\>10)
* noninvasive ventilation (NIV) therapy
40 Years
80 Years
ALL
No
Sponsors
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Fisher and Paykel Healthcare
INDUSTRY
Institut für Pneumologie Hagen Ambrock eV
INDUSTRY
Responsible Party
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Georg Nilius
Head of pneumologic department of Helios Klinik Hagen
Principal Investigators
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Georg Nilius, MD
Role: PRINCIPAL_INVESTIGATOR
Helios Klinik Ambrock
Locations
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Helios Klinik Ambrock
Hagen, North Rhine-Westphalia, Germany
Countries
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Other Identifiers
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AIRVOhome
Identifier Type: -
Identifier Source: org_study_id
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