An interventional study of NHF therapy and Long term Oxygen Therapy (LOT) in Pulmonary Disease, Chronic Obstructive, sponsored by Institut für Pneumologie Hagen Ambrock eV. Completed at 1 site in Germany. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-02-11.
Sponsored by Institut für Pneumologie Hagen Ambrock eV · Not applicable, Interventional, and Treatment
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 46 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
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Exclusion Criteria:
overnight nasal High Flow (NHF) therapy+ individually titrated supplemental oxygen (2-6 L/min),total 35 L/min, 4 weeks at home
Device: NHF therapy · Other: Long term Oxygen Therapy (LOT)
individually titrated supplemental oxygen (2-6 L/min), 4 weeks at home
Other: Long term Oxygen Therapy (LOT)
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.
Also known as: AIRVO 2, myAIRVO 2, PT101, PT100
Oxygen will individually be added to NHF in order to achieve stable oxygen saturation by pulse oximetry (SpO2) values of 88% to 92%.
Also known as: supplemental oxygen
mean overnight transcutaneous PCO2
In two baseline measurements the aim 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 polysomnographic sleep studies (PSG) during their hospital stay, under 20 L/min and 35 L/min NHF therapy in randomized order. Primary objective is the mean overnight transcutaneous PCO2 value, absolute as well as time spent \>50 mmHg.
Time frame: baseline
mean overnight transcutaneous PCO2
In home care monitoring is the aim to compare long term influences of NHF and LOT on PCO2 levels. Primary objective is the mean overnight transcutaneous PCO2 level measured after 4 weeks of each treatment phase.
Time frame: after 4 weeks
mean overnight transcutaneous PCO2
All patients will be monitored under NHF or another sufficient therapy for the next 12 month followed by another mean overnight transcutaneous PCO2 level measure.
Time frame: after 12 month
quality of life with Saint Georges Respiratory Questionnaire (SGRQ)
SGRQ is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.
Time frame: after 4 weeks, 8 weeks and 12 month
sleep quality
sleep quality, measured by sleep efficiency, e.g. total sleep time vs sleep period time from PSG report.
Time frame: baseline, after 4 weeks, after 8 weeks, after 12 month
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Institut für Pneumologie Hagen Ambrock eV