RecruitingNot ApplicableNCT03564236

Nasal High-Flow in COPD

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


Sponsor

Marieke Duiverman

Enrollment

136 participants

Start Date

Oct 1, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study tests whether using a high-flow nasal oxygen system (a device that delivers warm, humidified air through the nose at high rates) helps patients with severe COPD (chronic obstructive pulmonary disease) recover better from a flare-up (exacerbation) requiring hospitalization. **You may be eligible if...** - You have been diagnosed with moderate to very severe COPD (GOLD stage II–IV) - You have a history of at least 10 pack-years of smoking - You have been admitted to the hospital with a COPD flare-up - You have signs of respiratory failure (too much carbon dioxide or too little oxygen in your blood), but your blood is not dangerously acidic - You have had at least 2 COPD flare-ups in the past year requiring steroids, antibiotics, or hospital care **You may NOT be eligible if...** - You are in immediate need of a ventilator or intensive care - Your COPD is mild (GOLD stage I) or you do not have sufficient smoking history - Your blood acid-base levels indicate a more severe emergency Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENasal 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).\[3\]

OTHERStandard 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

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NCT03564236


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