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Effects of Dynamic Hyperinflation on the Left-ventricular Diastolic Function in Healthy Male Subjects

Effects of Dynamic Hyperinflation on the Left-ventricular Diastolic Function in Healthy Male Subjects

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03500822
Enrollment
14
Registered
2018-04-18
Start date
2016-11-30
Completion date
2017-09-29
Last updated
2018-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

dynamic hyperinflation, diastolic dysfunction, COPD, Chronic Obstructive Pulmonary Disease, Metronome-paced Tachypnea, Expiratory-stenosis Breathing

Brief summary

The aim of this study is to identify whether actively induced dynamic hyperinflation can cause left-ventricular diastolic dysfunction in healthy male subjects in order to explore the mechanisms of developing cardiac dysfunctions in patients with COPD.

Detailed description

Cardiovascular diseases, especially left-ventricular diastolic dysfunction, are among the most frequent reasons for morbidity and mortality in patients with chronic obstructive pulmonary disease (COPD). Dynamic hyperinflation is one of the expected pathophysiological mechanisms in the multifactorial genesis of this left-ventricular diastolic dysfunction in patients with COPD. The novel concept of Expiratory Stenosis Breathing (ESB) is based on the method of Metronome-Paced Tachypnea (MPT) of Cooper et al. Therefore the investigators use a metronome to indicate a specific breathing frequency (BF) and the relation of inspiration : expiration (I : E) in order to let subjects hyperinflate. Subjects get split into two groups each hyperinflating three times for 90sec by one of the two methods before doing a cross-over and switch groups to do the same in the other group. At the end of the 90sec there is a measurement of the Inspiratory Capacity (IC) and an echocardiography in order to objectify dynamic hyperinflation respectively the change in diastolic function. During ESB participants hyperinflate with a BF - 30/min and a I : E - 1 : 3. In addition they have to breathe through an expiratory-effective stenosis (3, 2 and 1,5mm) on the mouthpiece of the pneumotachograph to simulate the collapsing airways in COPD-patients. In contrast, during MPT subjects hyperinflate with a BF - 40/min, I : E - 1 : 1; BF - 40/min, I : E - 1 : 2; BF - 30/min, I : E - 1 : 2. During the whole trial investigators measure Intrinsic Positive Endexpiratory Pressure (PEEPi) in order to objectify the dynamic hyperinflation more significantly. The primary goal of this study is to assess if actively induced dynamic hyperinflation can affect diastolic function of the left ventricle. Furthermore a correlation between the extent of dynamic hyperinflation and diastolic dysfunction should be quantified. In addition measurement of PEEPi should validate the method of Metronome-paced Tachypnea (MPT) because the investigators hypothesize that this method does not simulate the pathophysiological circumstances in patients with COPD sufficiently.

Interventions

PROCEDUREMetronome-paced tachypnea

three cycles: breathing frequency (BF) - 40/min, inspiration : expiration (I : E) - 1 : 1; BF - 40/min, I : E - 1 : 2; BF - 30/min, I : E - 1 : 2

PROCEDUREExpiratory-stenosis breathing

three cycles: BF - /min, I : E - 1 : 3; stenosis: 3mm; 2mm; 1,5mm

Sponsors

Otto Wagner Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* BMI \<27 kg/m2 * Lifelong nonsmoker (currently non-smoking and up to now less than 100 cigarettes)

Exclusion criteria

* Obstructive pulmonary diseases (asthma, COPD) * Cardiovascular diseases (cardiac insufficiency, coronary heart diseases, hypertonia) * Other relevant pulmonary or cardiac diseases * Baseline E/A-ratio \<1

Design outcomes

Primary

MeasureTime frameDescription
E/A-ratio (absolute change between tidal breathing and smallest stenosis)At the end of each cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).E/A-ratio will be measured by transthoracic echocardiography (Vivid S9, general electric healthcare, Fairfield, USA) according to the valid standards of The European Association of Echocardiography. This parameter represents the left-ventricular diastolic function.

Secondary

MeasureTime frameDescription
deceleration time of the E-wave transmitral (msec)At the end of each cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).deceleration time will be measured by transthoracic echocardiography (Vivid S9, general electric healthcare, Fairfield, USA) according to the valid standards of The European Association of Echocardiography. This parameter represents the left-ventricular diastolic function.
Maximal diastolic transtricuspid flow (m/sec)At the end of each cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).Maximal diastolic transtricuspid flow will be measured by transthoracic echocardiography (Vivid S9, general electric healthcare, Fairfield, USA) according to the valid standards of The European Association of Echocardiography. This parameter represents the left-ventricular diastolic function.
E/E'-ratioAt the end of each cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).E/E'-ratio will be measured by transthoracic echocardiography (Vivid S9, general electric healthcare, Fairfield, USA) according to the valid standards of The European Association of Echocardiography. This parameter represents the left-ventricular diastolic function.
Inspiratory CapacityAt the end of each cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).Inspiratory Capacity will be measured with a pneumotachograph (VenThor D-22/5B, ThorMedical, Budapest, Hungary). It represents the extent of dynamic hyperinflation.
Dynamic Intrinsic Positive Endexpiratory Pressure:During each entire cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).To objectify the dynamic hyperinflation in addition to the Inspiratory Capacity, the Intrinsic Positive Endexpiratory Pressure will be measured by the invasive application of an esophageal balloon catheter (ICU-Lab, Kleistek Engineering, Bari, Italy).
Maximal late-systolic velocity of the lateral tricuspid valve in Tissue Doppler Imaging (cm/sec)At the end of each cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).Maximal late-systolic velocity will be measured by transthoracic echocardiography (Vivid S9, general electric healthcare, Fairfield, USA) according to the valid standards of The European Association of Echocardiography. This parameter represents the left-ventricular diastolic function.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026