Nasal High-Flow in COPD
ConditionCOPD Exacerbation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMarieke Duiverman
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Nasal High Flow Therapy
DeviceNasal 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
Other interventionStandard regular care of a COPD exacerbation
Treatment groups
136 Participants
are divided into 2 treatment groupsGroup A: Standard CareActive comparator 1 intervention
Group B: Nasal High Flow TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Health-Related Quality of Life
The primary outcome will be improvement in HRQoL, defined as the net response rate on the St. George Respiratory questionnaire (SGRQ) after 90 days
Time frame
90 daysSecondary outcomes
1
Treatment failure
Treatment failure of nHFT, defined as death, need for intensive care admission for respiratory failure, need for (non)-invasive mechanical ventilation, during the study period, in patients randomised to nHFT.
Time frame
90 days, follow-up up to 1 year2
Hospitalisations
Hospital length of stay of the index admission, readmissions, readmission characteristics and complications.
Time frame
90 days, follow-up up to 1 year3
Exacerbation frequency
Exacerbations will be defined as periods of symptom worsening treated with oral prednisolone and/or antibiotics.
Time frame
90 days, follow-up up to 1 year4
Severe Respiratory Insufficiency Questionnaire (SRI)
Subjective recovery during hospitalisation and thereafter will also be investigated by assessing the Severe Respiratory Insufficiency Questionnaire (SRI). This is a well-known and validated Health-Related quality of Life (HRQoL) questionnaire especially designed for patients with chronic hypercapnic respiratory failure containing 49 items measuring 7 conceptual domains of HRQoL: respiratory complaints, physical functioning, attendant symptoms and sleep, social relationships, anxiety, psychological well-being and social functioning, and a summary score. The domain scores are calculated by transforming the mean item score into a percentage ranging from 0 (most severely depressed health status as complaints/limitations are severe) to 100 (perfect health status with no complaints/limitations).
Time frame
90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Marieke Duiverman
Lead sponsor
University Medical Center Groningen
Sponsor institution
Rijnstate Hospital
Collaborator
Medisch Spectrum Twente
Collaborator
Albert Schweitzer Hospital
Collaborator
Technical University of Twente
Collaborator
Fisher and Paykel Healthcare
Collaborator
Vivisol
Collaborator
Source ClinicalTrials.gov