- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03270826
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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PE - Pernambuco
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Recife, PE - Pernambuco, Brasilien, 50740300
- Universidade Federal de Pernambuco
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Andet
- Tidsperspektiver: Tværsnit
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Displacement of blood volume of the lung
Tidsramme: 09/03/2018
|
Volume displacement per unit time measured by electrical impedance tomography through the impedance variation in Ohm (Ω).
|
09/03/2018
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Variation of pulmonary electrical impedance
Tidsramme: 09/03/2018
|
Variation between the final and initial impedance measured by electrical impedance tomography through the impedance variation in Ohm (Ω).
|
09/03/2018
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Lung volume
Tidsramme: 09/03/2018
|
Measurement of the amount of air that the lungs may contain at various points in the respiratory cycle.
|
09/03/2018
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Cláudia Thais Pinto, Ms, UFPE
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 23031990
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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