Can mobile echocardiographic and pulmonary function measurements be performed adequately and patient-friendly within 24 hours after admission to hospital and before discharge in COPD patients aged 65 years or over with an exacerbation?
ID
Source
Brief title
EXACT-study
Condition
- Heart failures
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Participants will receive the usual investigations and treatment necessary in
case of an exacerbation. After written informed consent, participants will
additionally undergo a pulmonary function test including spirometry with
flow-volume curves and echocardiographic assessment within 24 hours of
admission. Left and right sided left ventricular function will be assessed. As
is already common practice in the UMC Utrecht, blood tests will include
measurements of plasma B-type natriuretic peptide (BNP), and high sensitive
C-reactive protein at admission and discharge. Echocardiography and blood
analysis will be repeated before discharge (about 7 days after admission).
Echocardiographic and spirometric measurements will be performed at the
bed-side with mobile apparatuses at the time the patient is clinically
stabilised. It is common practice in the pulmonary department of the UMC
Utrecht to perform blood tests including measurements of C-reactive protein
(CRP) and plasma B-type natriuretic peptide.
Outcome measures:
- How many echocardiograms and spirometric measurements could be performed
completely and adequately?
- Are the results of these measurements interpretable (using a mobile bed-side
apparatus in patients experiencing dyspnoea)?
-What is the median (with 25-75% interquartile range) on the visual analoge
scale from 0-10, with 0= no burden at all, and 10= extremely burdensome?
To provide participants the most optimal possible treatment, possibly including
cardiovasvcular therapy, in all participants an expert panel will establish
presence or absence of ventricular dysfunction or heart failure (i.e.
ventricular dysfunction and symptoms indicative of heart failure). The panel
consisting of 2 cardiologists, a pulmonologist and a general practitioner (10)
will use all available diagnostic information including pulmonary function
test, echocardiographic results, and plasma B-type natriuretic peptide levels.
Earlier studies have shown that panel diagnoses in heart failure are highly
reproducible. (10;11) The panel will use the diagnostic criteria for heart
failure recommended by the European Society of Cardiology.(12)
(10) Rutten FH, Moons KGM, Cramer MJM, Grobbee DE, Zuithoff NPA, Lammers JWJ,
Hoes AW. Recoginsing heart failure in elderly patients with stable chronic
obstructive pulmonary disease in primary care: a cross-sectional diagnostic
study. BMJ 2005;331:1379.
(11) Cowie MR, Wood DA, Coats AJ, Thomson SG, Poole-Wilson PA, Suresh V et al.
Incidence and aetiology of heart failure; a population-based study. Eur Heart J
1999;20:421-8.
(12) Swedberg K, Cleland J, Dargie H, Drexler H, Follath F, Komajda M et al.
Guidelines for the diagnosis and treatment of chronic heart failure: executive
summary (update 2005): The Task Force for the DIagnosis and Treatment of
Chronic Heart Failure of the European Society of Cardiology. Eur Heart J
2005;26:1115-40.
Secondary outcome
none
Background summary
Chronic obstructive pulmonary disease (COPD) is a prevalent disease that is on
the increase, and is one of the leading causes of death world-wide.(1) Patients
with this disease frequently experience exacerbations which greatly affect the
quality of life and health of these patients, and place a great burden on
health services.(2) Nowadays, there is no precise definition of an exacerbation
of COPD.(2) An exacerbation of COPD is characterised by an abrupt increase in
symptoms. Increased dyspnoea and increased sputum volume and purulence are
generally seen as cardinal symptoms during an exacerbation.(2) Narrowing of
airways and worsening of oxygen saturation can be expected.(2) The changes in
lung function associated with exacerbations is generally small, but
importantly, lasting for up to three months.(2) In-patient mortality from
exacerbation range from 4 to 30%,(3) and mortality of patients with COPD is
independently related to the frequency of severe exacerbations.(4) The one year
mortality rate after admission in a US study was 43%, and heart failure was an
independent predictor of mortality.(5) Until now, attention has focussed on
bacteria, viruses, atypical micro-organisms such as mycoplasma and chlamydia
pneumoniae, and environmental pollution as causes for exacerbations of COPD.(6)
However, only in about half of the exacerbations there is objective evidence of
infection. Thus, additional factors seem to have a causal role in the
development of an exacerbation. Such an additional causal factor could be
(short lasting) ventricular dysfunction (left and/or right). The importance of
left ventricular dysfunction in stable primary care patients with COPD has
recently been demonstrated by our group.(7) Importantly, in the majority of the
patients with COPD concomitant heart failure (i.e. ventricular dysfunction with
symptoms indicative of heart failure) was previously unknown.
Indeed, overlap in symptoms and signs are important, ready at hand reasons for
not recognising heart failure in patients with COPD. However, also the fact
that hospitalised patients with COPD are treated by pulmonologists and those
with heart failure by cardiologists certainly influences the 'general neglect'
of concomitant presence of both syndromes.
Information about the left ventricular dysfunction during an exacerbation of
COPD is scarce, but prevalences of left ventricular systolic dysfunction of
20-30% have been reported.(8;9) These studies, however, were not performed
within 24 hours of hospital admission for an exacerbation of COPD, and did not
include diastolic dysfunction, right ventricular dysfunction, or follow-up
measurements. Moreover, feasibility of new bedside echocardiography facilities
has never been reported. Therefore, the question whether measurements within 24
hours by bed-side echocardiography is feasible and produces interpretable
results is unanswered, as is the question whether diastolic dysfunction or
right ventricular dysfunction can be assessed in such acute dyspnoeic patients
in a semi-sitting position.
(1) Murray CJ, Lopez AD. Alternative projections of mortality and disability by
cause 1990-2020: Global Burden of Disease Study. Lancet 1997;349:1498-504.
(2) Donaldson GC, Wedzicha JA. COPD exacerbations. 1: Epidemiology. Thorax
2006;61:164-8.
(3) Patil DP, Krishnan JA, Lechtzin N, Diette GB. In-hospital mortality
following acute exacerbation of chronic obstructive pulmonary disease. Arch
Intern Med 2003;163:1180-6.
(4) Soler-Cataluna JJ, Martinez-Garcia MA, Romaln SP, Salcedo E, Navarro M,
Ochando R. Severe exacerbations and mortality in patients with chronic
obstructive pulmonary disease. Thorax 2005;60:925-31.
(5) Connors AF, Jr., Dawson NV, Thomas C, Harrell FE, Jr., Desbiens N,
Fulkerson WJ, et al. Outcomes following acute exacerbation of severe chronic
obstructive lung disease. The SUPPORT investigators (Study to Understand
Prognoses and Preferences of Outcomes and Risks of Treatments). Am J Respro
Crit Care Med 1996;154:959-67.
(6) Sapey E, Stockley RA. COPD exacerbations. 2: Aetiology. Thorax
2006;61:250-8.
(7) Rutten FH, Cramer MJ, Grobbee DE, Sachs AP, Kirkels JH, Lammers JW, Hoes
AW. Unrecognized heart failure in elderly patients with stable chronic
obstructive pulmonary disease. Eur Heart J 2005;26:1887-94.
(8) Render ML, Weinstein AS, Blaustein AS. Left ventricular dysfunction in
deteriorating patients with chronic obstructive pulmonary disease. Chest
1995;107:162-8.
(9) McCullough PA, Hollander JE, Nowak RM, Storrow AB, Duc P, Omland T et al.
Uncovering heart failure in patients with a history of pulmonary disease:
rationale for the early use of B-type natriuretic peptide in the emergency
department. Acad Emerg Med 2003;10:198-204.
Study objective
Can mobile echocardiographic and pulmonary function measurements be performed
adequately and patient-friendly within 24 hours after admission to hospital and
before discharge in COPD patients aged 65 years or over with an exacerbation?
Study design
A cross-sectional diagnostic pilot study will be conducted in 20 consecutive
patients admitted at the pulmonary department of the University Medical Center
(UMC) Utrecht for an exacerbation of COPD. Patient burden will be assessed by a
visual analoge scale from 0-10, with 0= no burden at all, and 10= extremely
burdensome.
Study burden and risks
There is no risk associated with participation. Echocardiographic measurements
with radio frequency waves and spirometric measurements can be performed
without risk.
Participants will undergo the usual history taking, physical examination,
additional investigations and treatment as is necessary in patients with an
exacerbation of COPD. As is common practice. Participants will additionally
undergo a bedside echocardiogram and spirometry within 24 hours after admission
at a time that he/she is clinically stable. Echocardiographic measurements will
be repeated before discharge. By using mobile echocardiography and spirometry,
with measurements at the bedside, the burden for the participants will be as
small as possible (no transport to the laboratory, no waiting time).
Participants can profit when (newly detected) ventricular dysfunction or heart
failure is established, because they will receive adequate evidence-based
morbidity and mortality reducing cardiovascular treatment. There is no direct
group related benefit. Only when this pilot study shows that a large scale
study is feasible and our hypothesis is confirmed that ventricular dysfunction
and heart failure is common in these patients, then adjustment of the routine
diagnostic assessment of these patients and treatment should be changed in the
future.
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Patients with COPD, aged 65 years or over, who experience an exacerbation for which admission to the hospital is necessary.
Exclusion criteria
Patients with COPD, already known with a diagnosis of heart failure (assessment including echocardiography), patients unable or unwilling to give written informed consent, patients experiencing an exacerbation of COPD, however aged less than 65 years.
Design
Recruitment
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 |
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CCMO | NL18805.041.07 |