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Completed

NCT Number: NCT03500822

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

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Otto Wagner Spital, Dep. of Respiratory and Critical Care Medicine

Vienna, 1140, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metronome-paced tachypnea

Procedure

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

Other names: MPT

Expiratory-stenosis breathing

Procedure

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

Other names: ESB

Primary outcomes

  1. E/A-ratio (absolute change between tidal breathing and smallest stenosis)

    Time frame: 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 outcomes

  1. E/E'-ratio

    Time frame: At 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.

  2. deceleration time of the E-wave transmitral (msec)

    Time frame: 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.

  3. Maximal diastolic transtricuspid flow (m/sec)

    Time frame: 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.

  4. Maximal late-systolic velocity of the lateral tricuspid valve in Tissue Doppler Imaging (cm/sec)

    Time frame: 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.

  5. Inspiratory Capacity

    Time frame: At 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.

  6. Dynamic Intrinsic Positive Endexpiratory Pressure:

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Otto Wagner Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 18, 2018
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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