Physiological Behavior of Respiratory Maneuvers

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Brazil
  • PE - Pernambuco
    • Recife, PE - Pernambuco, Brazil, 50740300
      • Universidade Federal de Pernambuco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

The study sample will be composed of healthy male volunteers.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Displacement of blood volume of the lung	Volume displacement per unit time measured by electrical impedance tomography through the impedance variation in Ohm (Ω).	09/03/2018

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation of pulmonary electrical impedance	Variation between the final and initial impedance measured by electrical impedance tomography through the impedance variation in Ohm (Ω).	09/03/2018

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung volume	Measurement of the amount of air that the lungs may contain at various points in the respiratory cycle.	09/03/2018

Collaborators and Investigators

• Sponsor: Universidade Federal de Pernambuco
• Investigators: Principal Investigator: Cláudia Thais Pinto, Ms, UFPE

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2017
• Primary Completion (Actual): February 20, 2018
• Study Completion (Actual): March 23, 2018

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: August 30, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): May 4, 2018
• Last Update Submitted That Met QC Criteria: May 1, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 23031990

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No