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Efficacy and Physiology of Nasal High Flow Therapy

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ClinicalTrials.gov Identifier: NCT02083120
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : February 11, 2019
Sponsor:
Collaborator:
Fisher and Paykel Healthcare
Information provided by (Responsible Party):
Georg Nilius, Helios Klinik Ambrock

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Device: NHF therapy Other: Long term Oxygen Therapy (LOT) Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2014
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Device: 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.
Other Names:
  • AIRVO 2
  • myAIRVO 2
  • PT101
  • PT100

Other: 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 Name: supplemental oxygen

Active Comparator: Long term Oxygen Therapy (LOT)
individually titrated supplemental oxygen (2-6 L/min), 4 weeks at home
Other: 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 Name: supplemental oxygen




Primary Outcome Measures :
  1. mean overnight transcutaneous PCO2 [ Time Frame: baseline ]

    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.


  2. mean overnight transcutaneous PCO2 [ Time Frame: after 4 weeks ]
    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.

  3. mean overnight transcutaneous PCO2 [ Time Frame: after 12 month ]
    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.


Secondary Outcome Measures :
  1. quality of life with Saint Georges Respiratory Questionnaire (SGRQ) [ Time Frame: after 4 weeks, 8 weeks and 12 month ]
    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.


Other Outcome Measures:
  1. sleep quality [ Time Frame: baseline, after 4 weeks, after 8 weeks, after 12 month ]
    sleep quality, measured by sleep efficiency, e.g. total sleep time vs sleep period time from PSG report.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 40-80
  • Male and female
  • COPD patients with chronic respiratory insufficiency (pH >7.35 and PCO2 > 50mmHg)
  • Stable respiratory situation

Exclusion Criteria:

  • Decompensated heart, liver or kidney failure.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083120


Locations
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Germany
Helios Klinik Ambrock
Hagen, NRW, Germany, 58091
Sponsors and Collaborators
Institut für Pneumologie Hagen Ambrock eV
Fisher and Paykel Healthcare
Investigators
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Principal Investigator: Georg Nilius, MD Helios Klinik Ambrock
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Responsible Party: Georg Nilius, Head of pneumologic department of Helios Klinik Hagen, Helios Klinik Ambrock
ClinicalTrials.gov Identifier: NCT02083120    
Other Study ID Numbers: AIRVOhome
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Keywords provided by Georg Nilius, Helios Klinik Ambrock:
high flow
COPD
AIRVO
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive