Physiological Behavior of Respiratory Maneuvers

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03270826
• Other study ID #: 23031990
• Status: Completed
• Start date: April 7, 2017
• Est. completion date: March 23, 2018

Study information

• Verified date: May 2018
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 23, 2018
• Est. primary completion date: February 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy Volunteers

Locations

Country	Name	City	State
Brazil	Universidade Federal de Pernambuco	Recife	PE - Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lung volume	Measurement of the amount of air that the lungs may contain at various points in the respiratory cycle.	09/03/2018
Primary	Displacement of blood volume of the lung	Volume displacement per unit time measured by electrical impedance tomography through the impedance variation in Ohm (O).	09/03/2018
Secondary	Variation of pulmonary electrical impedance	Variation between the final and initial impedance measured by electrical impedance tomography through the impedance variation in Ohm (O).	09/03/2018