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…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Health-Related Quality of Life
Secondary outcome
1. 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.
Participants will be asked for separate informed consent to monitor treatment
failure after the formal study period in order to monitor long-term effects.
2. Hospital length of stay of the index admission, readmissions, readmission
characteristics and complications. Participants will be asked for separate
informed consent to monitor readmissions after the formal study period in order
to monitor long-term effects.
3. Exacerbation frequency, exacerbations will be defined as periods of symptom
worsening treated with oral prednisolone and/or antibiotics. Participants will
be asked for separate informed consent to monitor exacerbation frequency after
the formal study period in order to monitor long-term effects.
4. HRQoL and symptoms: Subjective recovery during hospitalisation and
thereafter will be investigated by assessing the SGRQ,[21] the Severe
Respiratory Insufficiency (SRI) questionnaire[22], and the COPD Clinical
questionnaire (CCQ)[23], the Euroquol 5-D questionnaire (EQ-5D) and the Cough
and Sputum Assessment Questionnaire (CASA-Q), the Leicester Cough Questionnaire
(LCQ), the modified Medical Research Council Dyspnoea Scale (mMRC), and the
Work Productivity and Activity Impairment Questionnaire (WPAI).Furthermore, a
questionnaire to assess the use (comfort & adverse events) of nHFT will be
evaluated.
5. Gas exchange will be monitored with both arterial blood gases during
spontaneous breathing at daytime and nocturnal transcutaneous monitoring while
on the prescribed therapy.
6. Functional capacity will be assessed at discharge and 90 days thereafter (T1
and T3) by means of calculating daily activity level, measured with a step
counter. Patients will wear the step counter for one week at home.
7. Assessment of cardiac function. An electrocardiogram (ECG) and blood
pressure measurements will be performed. The N-terminal of the brain
natriuretic peptide (NTproBNP) will be assessed by routine laboratory methods.
8. Compliance with the nHFT device will be read out from the compliance logs
stored in the device when patients visit the outpatient clinic.
9. Cost-effectiveness will be investigated by estimating the healthcare costs
of nHFT and usual care and the HRQoL gains of the two options.
10. Mechanism of the COPD exacerbation will be assessed by peripheral blood
analysis, sputum collection and nasal epithelium collection.
We will incorporate, in collaboration with the UT, a new methodology to control
and monitor the effect of nHFT. To limit patient effort, we will maximize the
use of non-invasive measurement methods or experimental models, which use the
data of the patient trial. We will investigate patient breathing effort by
surface electromyography and work of breathing analyses, output by measuring
breathing patterns and lung function, in collaboration with the technical
University Twente.
Background summary
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.
Study 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, Noordwest Ziekenhuisgroep,
Ommelander Ziekenhuis Groep (OZG), the University of Twente, Fisher and Paykel
Healthcare ltd, and Vivisol Nederland BV collaborating.
One hundred fifty-eight patients hospitalised with a COPD exacerbation will be
randomised to standard care or nHFT (>= 6 hours/day) during hospitalisation and
the 90 days after discharge, as added to standard care. The primary outcome
will be improvement in HRQoL after 90 days.
Intervention
Nasal High flow Therapy
Study burden and risks
Patients will start the intervention in the hospital. nHFT is a widely used
therapy in infants and on the intensive care unit, and side-effects are usually
limited. Furthermore, patients are not completely dependent on their device, as
it is meant as an add-on. Therefore we do not expect serious side-effects or
safety issues with regard to the therapy itself.
During hospitalisation and afterwards, during a control visit after 2 weeks and
after 3 months, a number of tests will be performed, for which we carefully
weighted burden to necessary data retrieval to get reliable study results and
an effective therapy. Most measurements are part of regular care. In a subgroup
of patients we will perform additional measurements to get more insight into
working mechanisms and optimal settings, the secondary aim of our proposal.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
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.
• At least 1 COPD exacerbation 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)
• Being admitted to the hospital with a COPD exacerbation
• 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).
• Already on non-invasive ventilation or nasal high flow therapy (at home
or during the exacerbation)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66206.042.18 |
| Other | UMCG research register 201800398; Clinical Trials NCT03564236 |