Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
136 participants
INTERVENTIONAL
2018-10-01
2025-12-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard Care
Standard care is provided according to our local COPD exacerbation protocol. All patients are treated with:
* oral prednisolone 40 mg/day for 5 days;
* antibiotics prescribed according to the following criteria: fever (body temperature \> 38.5 degrees Celsius), elevated C-reactive protein (CRP) \>50, change in sputum colour, and/or according to the physician's decision of severe illness, and/or in all patients with a FEV1 \<30% of predicted;
* high dose inhaled corticosteroids, beta-agonists and or anticholinergics.
* Oxygen will be prescribed in all patients through a standard low flow system in order to maintain an adequate arterial oxygen saturation (Sa,O2) Patients will be discharged with regular low flow oxygen once they fulfil the criteria for long-term oxygen therapy.
Standard care
Standard regular care of a COPD exacerbation
Nasal High Flow Therapy
In addition to the standard care described above, patients in the intervention group will be treated with:
* nHFT, set at 30-50 L/min flow with oxygen to achieve an adequate oxygen saturation. nHFT is prescribed for at least 6 hours, but patients are stimulated to use the device as much as possible during the hospital stay.
* During periods without HFT through a standard low flow system, to maintain an adequate arterial oxygen saturation (Sa,O2) (between 90-92% if patients are concomitantly hypercapnic, and between 90-95% if patients are normocapnic). Flow rates are titrated accordingly.
* After discharge patients in the nHFT arm will continue the prescribed therapy at home for 90 subsequent days.
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).\[3\]
Interventions
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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).\[3\]
Standard care
Standard regular care of a COPD exacerbation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
ALL
No
Sponsors
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Rijnstate Hospital
OTHER
Medisch Spectrum Twente
OTHER
Albert Schweitzer Hospital
OTHER
Technical University of Twente
OTHER
Fisher and Paykel Healthcare
INDUSTRY
Vivisol
OTHER
Marieke Duiverman
OTHER
Responsible Party
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Marieke Duiverman
Principal Investigator
Locations
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Rijnstate Hospital
Arnhem, , Netherlands
Albert Schweizer ziekenhuis
Dordrecht, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Simone Elferink
Role: primary
Christiaan Theunisse
Role: primary
Marieke L Duiverman, MD PhD
Role: primary
Other Identifiers
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201800398
Identifier Type: -
Identifier Source: org_study_id