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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-09-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of the Effect of Inhaled Anesthetics on Diastolic Heart Function Using a Doppler-derived Efficiency Index

NCT00907439

Diastolic Dysfunction Coronary Artery Disease General Anesthesia

COMPLETED

Impact of Pacing Mode and Diastolic Function on Cardiac Output

NCT04068233

Diastolic Function Cardiac Output Pacemaker Stimulation Mode +2 more

COMPLETED NA

LEft Atrial Pacing in Diastolic Heart Failure

NCT01618981

Heart Failure With Preserved Ejection Fraction Atrial Dyssynchrony Syndrome Left Atrio-ventricular Asynchrony

COMPLETED NA

Validation of New Non-Invasive Parameters of Diastolic Suction in the Left Ventricle

NCT02315859

Diastolic Heart Failure

COMPLETED

Left Ventricular Dyssynchrony in Multipole Pacing

NCT03187470

Heart Failure，Congestive

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Metronome-paced tachypnea

Dynamic hyperinflation by the method of metronome-paced tachypnea.

Group Type EXPERIMENTAL

Metronome-paced tachypnea

Intervention Type 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

Exspiratory-stenosis breathing

Dynamic hyperinflation by the method of expiratory-stenosis breathing.

Group Type EXPERIMENTAL

Expiratory-stenosis breathing

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

Expiratory-stenosis breathing

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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MPT ESB

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Georg-Christian Funk

Head of Intensive Care Unit, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Georg C Funk, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Respiratory and Critical Care Medicine and Ludwig-Boltzmann Institute for COPD and Respiratory Epidemiology, Otto Wagner Hospital, Vienna