RECRUITINGINTERVENTIONAL

Nasal High-Flow in COPD

Nasal High-Flow Therapy to Treat COPD Exacerbations: a Matter of Monitoring and Controlling Settings?

About This Trial

Rationale: Chronic Obstructive Pulmonary Disease (COPD) is a disease with high morbidity and mortality worldwide. COPD exacerbations are the important contributor to disease deterioration and decrease in health-related quality of life (HRQoL). Since therapeutic options to treat exacerbations effectively are limited, many patients have persistent loss of vital functioning and suffer from frequent re-hospitalisations. Nasal high flow therapy (nHFT) is an innovative therapy that provides humidified and heated air through a nasal cannula. Although there is some preliminary evidence that nHFT is effective in stable COPD patients, there are no data at all regarding the effectiveness of nHFT in COPD exacerbations. A key problem in the implementation of nHFT is that the underlying working mechanisms are not clear and therefore the appropriate way to apply nHFT is unknown. Objective: The aim of the present study is to prove efficacy of nHFT in enhancing recovery from COPD exacerbations. We aim to improve the effectiveness of nHFT by developing new technologies to control and monitor the effect of nHFT and by providing background for optimal settings of nHFT. Study design: The study will be designed as a multicentre randomised controlled trial, with the University Medical Center Groningen, the "Medisch Spectrum Twente", "Albert Schweizer ziekenhuis", Rijnstate hospital, and the University of Twente, collaborating. Study population: One hundred thirty-six patients with known COPD GOLD stage II to IV and hypoxemic respiratory failure hospitalised with a COPD exacerbation will be included. Intervention (if applicable): Patients will be randomised to standard care or nHFT (≥ 6 hours/day) during hospitalisation and the 90 days after discharge, as added to standard care. Main study parameters/endpoints: The primary outcome will be improvement in HRQoL after 90 days.

Who May Be Eligible (Plain English)

Who May Qualify: Patients have to fulfil all of the following Who May Qualify: - History of COPD Global Initiative of Obstructive Lung Diseases (GOLD) stage II to IV (FEV1\< 80% of predicted with an FEV1/forced vital capacity (FVC) ratio \<70), with a history of at least 10 pack years smoking. - Being admitted to the hospital with a COPD exacerbation - Signs of compensated respiratory failure (hypercapnia (partial arterial carbon dioxide pressure (PaCO2) ≥ 6.0 kPa and/or hypoxemia (partial arterial oxygen pressure (PaO2) ≤ 8.0 kPa at room air), with pH \> 7.34 - At least 2 COPD exacerbations in the year prior to the index hospital admission (exacerbation defined as worsening of pulmonary symptoms requiring oral steroids and/or antibiotics and/or hospital admission) - Written willing to sign a consent form is obtained Who Should NOT Join This Trial: A potential subject who meets any of the following criteria will be excluded from participation in this study: - No lung function data available - The presence of another acute condition (e.g. pneumonia, acute congestive heart failure, pulmonary embolus) explaining or significantly contributing to the index admission - Inability to comply with the tests - The presence of another chronic lung disease (e.g. asthma, restrictive lung disease). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: Patients have to fulfil all of the following inclusion criteria: * History of COPD Global Initiative of Obstructive Lung Diseases (GOLD) stage II to IV (FEV1\< 80% of predicted with an FEV1/forced vital capacity (FVC) ratio \<70), with a history of at least 10 pack years smoking. * Being admitted to the hospital with a COPD exacerbation * Signs of compensated respiratory failure (hypercapnia (partial arterial carbon dioxide pressure (PaCO2) ≥ 6.0 kPa and/or hypoxemia (partial arterial oxygen pressure (PaO2) ≤ 8.0 kPa at room air), with pH \> 7.34 * At least 2 COPD exacerbations in the year prior to the index hospital admission (exacerbation defined as worsening of pulmonary symptoms requiring oral steroids and/or antibiotics and/or hospital admission) * Written informed consent is obtained Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * No lung function data available * The presence of another acute condition (e.g. pneumonia, acute congestive heart failure, pulmonary embolus) explaining or significantly contributing to the index admission * Inability to comply with the tests * The presence of another chronic lung disease (e.g. asthma, restrictive lung disease).

Treatments Being Tested

DEVICE

Nasal High Flow Therapy

Nasal High Flow Therapy (nHFT) is an innovative therapy for patients with respiratory diseases. It supplies heated, humidified, and oxygen-enriched air at high flow rates through a nasal cannula. Because the air is provided through an open system with a nasal cannula, it is relatively easy to apply and suggested to be very comfortable for patients. The technique has been shown to be effective in the treatment of hypoxemic respiratory failure, mainly in neonates\[2\] and patients with acute hypoxemic respiratory failure on intensive care units (ICU).\[3\]

OTHER

Standard care

Standard regular care of a COPD exacerbation

Locations (3)

Rijnstate Hospital

Arnhem, Netherlands

Albert Schweizer ziekenhuis

Dordrecht, Netherlands

University Medical Center Groningen

Groningen, Netherlands