Clinical trial NCT03270826: Physiological Behavior of Respiratory Maneuvers
Official title: Physiological Behavior of Respiratory Maneuvers Through Electrical Impedance Tomography and Optoelectronic Plethymography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study sample will be composed of healthy male volunteers.

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Displacement of blood volume of the lung
timeFrame: 09/03/2018
Secondary outcomes:
measure: Variation of pulmonary electrical impedance
timeFrame: 09/03/2018
Other outcomes:
measure: Lung volume
timeFrame: 09/03/2018
Locations:
city: Recife
country: Brazil
facility: Universidade Federal de Pernambuco
state: PE - Pernambuco
Study officials:
affiliation: UFPE
name: Cláudia Thais Pinto, Ms
role: PRINCIPAL_INVESTIGATOR
References: