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

O

Otto Wagner Hospital

Status

Completed

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Procedure: Metronome-paced tachypnea
Procedure: Expiratory-stenosis breathing

Study type

Interventional

Funder types

Other

Identifiers

NCT03500822
Hyperstolic-COPD

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

Male

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

14 participants in 2 patient groups

Metronome-paced tachypnea
Experimental group
Description:
Dynamic hyperinflation by the method of metronome-paced tachypnea.
Treatment:
Procedure: Metronome-paced tachypnea
Exspiratory-stenosis breathing
Experimental group
Description:
Dynamic hyperinflation by the method of expiratory-stenosis breathing.
Treatment:
Procedure: Expiratory-stenosis breathing

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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