Optoelectronic Pletysmography and Diaphragmatic Thickness in Heart Failure Patients

Heart Failure Clinical Trial

Official title:

Effect of Cardiomegaly Associated With Inspiratory Muscle Weakness on Diaphragm Thickness and Chest Wall Volume Distribution in Patients With Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02481388
• Other study ID #: jasiel02
• Status: Recruiting
• Phase: N/A
• First received: June 22, 2015
• Last updated: June 24, 2015
• Start date: May 2014

Study information

• Verified date: June 2015
• Source: Universidade Federal de Pernambuco
• Contact: Daniella C Brandao, PhD
• Phone: +558121268496
• Email: daniellacunha[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Comittee of Ethics in Research
• Study type: Observational

Clinical Trial Summary

The investigators aimed to evaluate the effects of cardiomegaly associated with inspiratory muscle weakness on tricompartmental distribution of chest wall volumes, on the thickness of the right hemidiaphragm and on the contraction speed of the respiratory muscles. As method of the present research, a pilot cross-sectional study was conducted with fourteen (14) patients with heart failure, functional class II and III, clinically stable, with cardiomegaly. Two groups were formed: one group with inspiratory muscle weakness (WG) (maximal inspiratory pressure - MIP <70% predicted MIP) and a control group without weakness (CG). The pulmonary and respiratory muscle functions were assessed by spirometry and manometer, respectively. Before and after maximal exercise test, optoelectronic plethysmography was performed to evaluate the distribution of volumes, the kinematics and the contraction speed of chest wall muscles. The high-resolution ultrasonography was also used before and after the maximum test for obtaining diaphragmatic thickness

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Both sexes, 18-60 years;

• Functional Class II-III according to the New York Heart Association;

• Echocardiography of the last six months showing showing left ventricular ejection fraction (LVEF) = 45% measured by Teichholz method;

• Echocardiography the last six months showing cardiac hypertrophy (Diameter of Left Ventricular Diastolic (LVDD)> 54 mm, diameter of Systolic Left Ventricular (LVSD)> 34mm) 30 measured by Teichholz method;

• Optimized by the medical point of view and

• Clinical stability

Exclusion Criteria:

• Unstable angina; myocardial infarction or heart surgery up to three months before the survey;

• Orthopedic diseases, infectious or chronic metabolic diseases;

• The relation between forced expiratory volume in the first second and forced vital capacity (FEV1 / FVC) <70% of predicted characterizing obstructive respiratory disorder and

• Active smokers.

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Maximal exercise ramp test
The maximal exercise ramp test, symptom-limited, performed by all patients in the study was performed based on treadmill ramp protocol through ErgoPC Elite® software associated with 12-channels electrocardiogram. Respiratory variables were obtained in standard conditions of temperature, pressure and humidity (StPD), breath-by-breath, with the patient breathing through a face mask without leaks coupled to gas analyzer (Cortex - Metamax 3B, Germany).To ensure that patients reached maximum effort during the examination, only the tests which patients obtain a respiratory exchange ratio (RR) =1.1 were accepted .

Locations

Country	Name	City	State
Brazil	Laboratório de Fisiologia e Fisioterapia Cardiopulmonar	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Aliverti A, Cala SJ, Duranti R, Ferrigno G, Kenyon CM, Pedotti A, Scano G, Sliwinski P, Macklem PT, Yan S. Human respiratory muscle actions and control during exercise. J Appl Physiol (1985). 1997 Oct;83(4):1256-69. — View Citation

Brandão DC, Lage SM, Britto RR, Parreira VF, de Oliveira WA Jr, Martins SM, Aliverti A, de Andrade Carvalho L, do Nascimento Junior JF, Alcoforado L, Remígio I, de Andrade AD. Chest wall regional volume in heart failure patients during inspiratory loaded — View Citation

Chiappa GR, Roseguini BT, Vieira PJ, Alves CN, Tavares A, Winkelmann ER, Ferlin EL, Stein R, Ribeiro JP. Inspiratory muscle training improves blood flow to resting and exercising limbs in patients with chronic heart failure. J Am Coll Cardiol. 2008 Apr 29;51(17):1663-71. doi: 10.1016/j.jacc.2007.12.045. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaphragmatic thickness	A high-definition ultrasound in the the B mode with linear transducer of 7.5 megahertz was used to measure diaphragmatic thickness. In the lateral decubitus position, the transducer was positioned perpendicular to the chest, between the eighth and ninth intercostal spaces between the right anterior and medium axillary lines. Diaphragm was identified by two hyperechoic (bright) lines parallel to the pleural and parietal membranes respectively. The measurement of diaphragm thickness was held from the middle of the pleural line to the middle of peritoneal. The average of 3 final measures taken at the apposition zone obtained: at functional residual capacity (thickness of the relaxed diaphragm - Erel) at the end of the total lung capacity (thickness of the diaphragm contracted - Econt) and during a maximal inspiratory pressure maneuver from functional residual capacity.	30 minutes	Yes
Primary	Chest Wall tricompartmental volumes	The images generated by the triangulation of the infra-red light reflected by 89 markers placed over volunteers' chest walls and captured by 8 cameras allows the visualization of the same thoraxes as entire structure and in its own tricompartmental division: pulmonary rib cage (RCp), abdominal rib age (RCab) and abdomen (AB). Each compartment can be evaluated in terms of their volume variation across the recorded respiratory cycle.	30 minutes	Yes