Objective: To investigate posture dependent small airway obstruction in subjects with obesity. To study the capacity of FOT as a measurement tool for small airways obstruction.
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
FEF25-75/FVC
mid inspiratory Xrs minus mid expiratory Xrs at 8 Herz (cmH20.s/L)
Secondary outcome
Spirometry: FEV1(L), FVC(L), IC(L), VC max(L),
Helium rebreathing: FRC, ERV, TLC
Body plethysmography: Pressure-flow loop
Forced oscillation technique: Rrs-8 (cmH20.s/L)
Frequence dependency
Resonance frequency
Baseline Xrs, Rrs
Anthropometrical data
Background summary
Obesity is a cause of dyspnea due to mechanical impairment of pulmonary
ventilation. One of the causes of this impairment is expiratory flow
limitation, which is related to decreased lung volume. As a result, obesity can
cause an asthma-like symptoms. Therefore, some patients with obesity are
misdiagnosed as asthma-patients, and treated with asthma medication. The
effects of bronchodilators on the mechanical airway obstruction in obese
subjects have not been well established.
Posture also has effect on lung volumes: they are decreased in supine
position. Therfore, the interaction of obesity and supine posture might result
in a larger decrease in lung volumes, and thereby a more increased airflow
limitation. It has been suggested that both obesity and supine posture result
in an obstruction of peripheral airways. Such an obstruction can be measured by
spirometry, using the ratio of forced expiratory flow between 25 and 75% and
vital capacity. This measure is highly variable, however.
The forced oscillation technique (FOT) is a non-invasive method to measure the
resistance and reactance of the respiratory system. Particularly the reactance
has been shown useful in the measurement of airflow limitations.
We hypothesize that obesity causes a posture dependent end- expiratory airflow
limitation due to a mechanical compression of lung tissue, resulting in
increased resistance and reactance in the airways. Therefore, we expect no
protective effect of bronchodilation by salbutamol. We expect that reactance
measured by FOT detects differences in airflow limitation and correlates with
airflow limitation as measured by spirometry.
Study objective
Objective: To investigate posture dependent small airway obstruction in
subjects with obesity. To study the capacity of FOT as a measurement tool for
small airways obstruction.
Study design
Observational research without invasive measurements (see flowchart pag 11)
Study burden and risks
Participating in this study is low risk. Spirometry, body plethysmography and
helium rebreathing are standard diagnostic tests performed in the pulmonary
function test department. No extra risk is foreseen in this study. Forced
oscillation technique is not (yet) a standard diagnostic test. It is a
non-invasive test. No adverse events are foreseen due to this test. Benefit is
an improvement in the assessment of bronchial obstruction with a technique that
does not require patient cooperation and can be applied in situations where the
patient really has complaints. Benefit could be improvement in diagnostics in
patients with obesity, saving unnecessary treatment with inhaled medicaments.
Wilhelminalaan 12
1815 JD Alkmaar
Nederland
Wilhelminalaan 12
1815 JD Alkmaar
Nederland
Listed location countries
Age
Inclusion criteria
Inclusion criteria obese population:;Male/female, age 25-60
BMI (body mass index) 30-40 kg/m2
Non or ex smokers with < 10 packyears;Inclusion criteria control population:;Male/female, age 25-60
BMI (body mass index) 18.5-25 kg/m2
Non or ex smokers with <10 packyears
Exclusion criteria
asthma
COPD (FEV1/IVC<0.70)
reversibility >9% in FEV1 (400 microgram salbutamol)
other significant neuromuscular, cardiac or lung disease;Exclusie criteria controle population:
asthma
COPD (FEV1/FVC<70)
any other significant neuromuscular, cardial of pulmonary disease
reversibility >9% in FEV1 (400 microgram salbutamol);Exclusion criteria control population:
No asthma
No COPD (FEV1/FVC<70)
No other significant neuromuscular, cardiac or lung disease
No reversibility >9% in FEV1 (400 microgram salbutamol)
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 |
---|---|
CCMO | NL21919.094.08 |