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

April 15, 2018 updated by: Georg-Christian Funk, Otto Wagner Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1140
        • Otto Wagner Spital, Dep. of Respiratory and Critical Care Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metronome-paced tachypnea
Dynamic hyperinflation by the method of metronome-paced tachypnea.
Procedure: Metronome-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
Other Names:
  • MPT
Experimental: Exspiratory-stenosis breathing
Dynamic hyperinflation by the method of expiratory-stenosis breathing.
Procedure: Expiratory-stenosis breathing
three cycles: BF - /min, I : E - 1 : 3; stenosis: 3mm; 2mm; 1,5mm
Other Names:
  • ESB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the end of each cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the end of each cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).
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.
At the end of each cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).
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.
At the end of each cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).
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.
At the end of each cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).
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.
At the end of each cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).
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).
During each entire cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otto Wagner Hospital

Investigators

  • Principal Investigator: Georg C Funk, Assoc. Prof., Department of Respiratory and Critical Care Medicine and Ludwig-Boltzmann Institute for COPD and Respiratory Epidemiology, Otto Wagner Hospital, Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 29, 2017

Study Registration Dates

First Submitted

February 9, 2018

First Submitted That Met QC Criteria

April 15, 2018

First Posted (Actual)

April 18, 2018

Study Record Updates

Last Update Posted (Actual)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 15, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hyperstolic-COPD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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