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Completed

NCT Number: NCT03270826

Physiological Behavior of Respiratory Maneuvers

Introduction: new methods of evaluation of respiratory function, such as electrical impedance tomography (EIT) and optoelectronic plethysmography (OEP), have been used to measure regional pulmonary ventilation and the variation of tricompartmental volumes of the thoracic cavity, respectively. Analysis of these instruments during maximal respiratory maneuvers with monitoring of esophageal pressure may probably provide additional information on the physiological behavior of the cardiorespiratory system during EIT and OEP maneuvers. Objectives: To describe the physiological behavior of maximal respiratory maneuvers through the electrical impedance tomography and optoelectronic plethysmography in healthy men.

METHODS: This is a cross-sectional study involving 10 healthy male volunteers. The development of the method will take place in 3 stages. The first step corresponds to the characterization of the inspiratory and expiratory curves in the respiratory cycle generated by the impedance variation (ΔZ), the mobility of the chest wall and the pulmonary volume curve during maximal respiratory maneuvers. 2nd stage: verification of the correlation between the variables Step 3: Estimate the dislocated blood volume of the lung through previous analyzes.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Male

Study type

Observational

Primary location

Universidade Federal de Pernambuco

Recife, PE - Pernambuco, 50740300, Brazil

About this study

The physiological repercussions resulting from the maximal respiratory maneuvers together with the synchronized analysis of the chest cavity mobility, pulmonary volume , pulmonary impedance and measurement of Oesophageal pressure is not known. Therefore, this study aims to describe the physiological behavior of maximal respiratory maneuvers through the synchronization between electrical impedance tomography and optoelectronic plethysmography in healthy men.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Will be included in the study male volunteers,
  • BMI greater than or equal to 18.5 and less than 25 kg / m2, considered adequate or eutrophic (MS, 2011)
  • Chest circumference between 44 and 55 cm if fitted to the electrical impedance tomography (EIT) strap size P or M;
  • systolic blood pressure lower than 140 mmHg and greater than 100 mmHg
  • diastolic blood pressure greater than 60 mmHg and lower than 90 mmHg (VI Brazilian Guidelines for Hypertension, 2010)
  • without reports of cardiovascular or pulmonary diseases and symptoms Last month.

Exclusion criteria

  • Volunteers who refuse to participate in the study will be excluded from the survey;
  • Presence of cardiac dysfunction assessed by echocardiography;
  • Altered pulmonary function by spirometry (PEREIRA et al, 2001) and manovacuometry according to predicted values for healthy individuals (PESSOA et al, 2014).
  • Presence of tissue injury in the thorax;
  • Dysautonomia that may indicate dysfunction of the autonomic nervous system (ANS), with following clinical manifestations: seizures; epilepsy; Anhydrosis and hyperhidrosis; Neurogenic bladder (CASTRO et al, 1992); (Stewart et al., 2004 and 2005)
  • individuals who donated blood or had significant blood loss within 30 days prior to the start of the study (Navarro et al, 1997).

Treatment and study plan

Primary outcomes

  1. Displacement of blood volume of the lung

    Time frame: 09/03/2018

    Volume displacement per unit time measured by electrical impedance tomography through the impedance variation in Ohm (Ω).

Secondary outcomes

  1. Variation of pulmonary electrical impedance

    Time frame: 09/03/2018

    Variation between the final and initial impedance measured by electrical impedance tomography through the impedance variation in Ohm (Ω).

Other outcomes

  1. Lung volume

    Time frame: 09/03/2018

    Measurement of the amount of air that the lungs may contain at various points in the respiratory cycle.

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Official study title

Physiological Behavior of Respiratory Maneuvers Through Electrical Impedance Tomography and Optoelectronic Plethymography

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 1, 2017
Registry last updated
May 4, 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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