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

NCT03500822 | Completed

• 1 other identifier: Hyperstolic-COPD
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (6)

• E/E'-ratio

  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)

  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)

  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)

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

• Inspiratory Capacity

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

Study Arms (2)

Metronome-paced tachypnea

EXPERIMENTAL

Dynamic hyperinflation by the method of metronome-paced tachypnea.

Procedure: Metronome-paced tachypnea

Exspiratory-stenosis breathing

EXPERIMENTAL

Dynamic hyperinflation by the method of expiratory-stenosis breathing.

Procedure: Expiratory-stenosis breathing

Interventions

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

Also known as: MPT

Metronome-paced tachypnea

Expiratory-stenosis breathing PROCEDURE

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

Also known as: ESB

Exspiratory-stenosis breathing

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Otto Wagner Hospital: lead

Study Sites (1)

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

Vienna, 1140, Austria

Location

Related Publications (9)

• Cooper CB, Calligaro GL, Quinn MM, Eshaghian P, Coskun F, Abrazado M, Bateman ED, Raine RI. Determinants of dynamic hyperinflation during metronome-paced tachypnea in COPD and normal subjects. Respir Physiol Neurobiol. 2014 Jan 1;190:76-80. doi: 10.1016/j.resp.2013.08.002. Epub 2013 Aug 27.

  PMID: 23994176 BACKGROUND

• Weigt SS, Abrazado M, Kleerup EC, Tashkin DP, Cooper CB. Time course and degree of hyperinflation with metronome-paced tachypnea in COPD patients. COPD. 2008 Oct;5(5):298-304. doi: 10.1080/15412550802363428.

  PMID: 18972278 BACKGROUND

• Evangelista A, Flachskampf F, Lancellotti P, Badano L, Aguilar R, Monaghan M, Zamorano J, Nihoyannopoulos P; European Association of Echocardiography. European Association of Echocardiography recommendations for standardization of performance, digital storage and reporting of echocardiographic studies. Eur J Echocardiogr. 2008 Jul;9(4):438-48. doi: 10.1093/ejechocard/jen174.

  PMID: 18579482 BACKGROUND

• Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.

  PMID: 16055882 BACKGROUND

• Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guerin C, Patroniti N, Ranieri VM, Gattinoni L, Nava S, Terragni PP, Pesenti A, Tobin M, Mancebo J, Brochard L; PLUG Working Group (Acute Respiratory Failure Section of the European Society of Intensive Care Medicine). The application of esophageal pressure measurement in patients with respiratory failure. Am J Respir Crit Care Med. 2014 Mar 1;189(5):520-31. doi: 10.1164/rccm.201312-2193CI.

  PMID: 24467647 BACKGROUND

• Anthonisen NR, Connett JE, Enright PL, Manfreda J; Lung Health Study Research Group. Hospitalizations and mortality in the Lung Health Study. Am J Respir Crit Care Med. 2002 Aug 1;166(3):333-9. doi: 10.1164/rccm.2110093.

  PMID: 12153966 BACKGROUND

• Lopez-Sanchez M, Munoz-Esquerre M, Huertas D, Gonzalez-Costello J, Ribas J, Manresa F, Dorca J, Santos S. High Prevalence of Left Ventricle Diastolic Dysfunction in Severe COPD Associated with A Low Exercise Capacity: A Cross-Sectional Study. PLoS One. 2013 Jun 27;8(6):e68034. doi: 10.1371/journal.pone.0068034. Print 2013.

  PMID: 23826360 BACKGROUND

• Barr RG, Bluemke DA, Ahmed FS, Carr JJ, Enright PL, Hoffman EA, Jiang R, Kawut SM, Kronmal RA, Lima JA, Shahar E, Smith LJ, Watson KE. Percent emphysema, airflow obstruction, and impaired left ventricular filling. N Engl J Med. 2010 Jan 21;362(3):217-27. doi: 10.1056/NEJMoa0808836.

  PMID: 20089972 BACKGROUND

• Urban MH, Mayr AK, Schmidt I, Grasmuk-Siegl E, Burghuber OC, Funk GC. Effects of Dynamic Hyperinflation on Left Ventricular Diastolic Function in Healthy Subjects - A Randomized Controlled Crossover Trial. Front Med (Lausanne). 2021 May 4;8:659108. doi: 10.3389/fmed.2021.659108. eCollection 2021.

  PMID: 34017848 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Intensive Care Unit, Principal Investigator

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: April 18, 2018
• Study Start: November 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 29, 2017
• Last Updated: April 18, 2018

Record last verified: 2018-04

Locations

AU (1)