Physiological Behavior of Respiratory Maneuvers

NCT ID: NCT03270826

Last Updated: 2018-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-07

Study Completion Date

2018-03-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidade Federal de Pernambuco

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cláudia Thais Pereira Pinto

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cláudia Thais Pinto, Ms

Role: PRINCIPAL_INVESTIGATOR

UFPE

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universidade Federal de Pernambuco

Recife, PE - Pernambuco, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

23031990

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.