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NCT Number: NCT02083120

Efficacy and Physiology of Nasal High Flow Therapy

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helios Klinik Ambrock

Hagen, North Rhine-Westphalia, 58091, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NHF therapy

Device

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

Long term Oxygen Therapy (LOT)

Other

Oxygen will individually be added to NHF in order to achieve stable oxygen saturation by pulse oximetry (SpO2) values of 88% to 92%.

Other names: supplemental oxygen

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Institut für Pneumologie Hagen Ambrock eV

Industry

Collaborators

  • Fisher and Paykel Healthcare

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 11, 2014
Registry last updated
Feb 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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