Healthy Individuals Clinical Trial
— LATLUNGSOfficial title:
Physiological Effects of Lateral Body Positioning on Regional Ventilation and Ultrasound Diaphragmatic Mobility in Healthy Subjects: an Experimental Study
Verified date | October 2023 |
Source | University of Pernambuco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this experimental study, with crossover design, is to analyze the effects of body lateralization applied at 30 degrees compared to the supine position on the distribution of ventilation and regional lung aeration in healthy individuals. The main study questions to be answered are: - Question 1: What are the immediate effects of 30 degree body lateralization on the distribution of regional ventilation and lung aeration in healthy individuals? - Question 2: What is the effect of body lateralization on diaphragmatic mobility in the dependent or non-dependent hemithorax? Participants will be submitted to changes in positioning in bed, considering a randomized sequence of interventions, between supine position and body lateralization at 30 degrees, using the Multicare bed (Linet, Czech Republic). The interventions were repeated twice each with a 30-minute washout in each sequence. Participants will perform assessment of lung function and respiratory muscle strength with the instruments: - Manovacuometry - Spirometry - Ventilometry - Respiratory Diagnostic Assistant The supine and body lateralization positions will be compared, with the primary outcomes being lung aeration and ventilation distribution assessed using Electrical Impedance Tomography. The secondary outcome will be diaphragmatic mobility measured through lung ultrasound. Groups: - Supine position - Body lateralization Effects - Lung aeration - Distribution of ventilation - Diaphragmatic mobility
Status | Completed |
Enrollment | 30 |
Est. completion date | October 25, 2023 |
Est. primary completion date | October 25, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 59 Years |
Eligibility | Inclusion Criteria: - Healthy individuals - Volunteers aged between 18 and 59 years old (youth/adults) - Volunteers of both sexes Exclusion Criteria: - Individuals with contraindications for the use of manovacuometry, spirometry, ventilometry will be excluded - Volunteers who did not tolerate the positioning or interventions - Individuals with Grade III obesity (BMI > 40) - Participants with below-normal prediction values for manovacuometry and spirometry according to predefined formulas for men and women - History of flu syndrome in the last seven days. |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital das Clínicas da UFPE | Recife | |
Brazil | Shirley Campos | Recife | Pernambuco |
Lead Sponsor | Collaborator |
---|---|
University of Pernambuco | Brazilian National Council for Scientific and Technological Development (CNPq), Coordination for the Improvement of Higher Education Personnel, Pernambuco Research Foundation (FACEPE), Universidade Federal de Pernambuco |
Brazil,
American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available. — View Citation
Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun. — View Citation
Testa A, Soldati G, Giannuzzi R, Berardi S, Portale G, Gentiloni Silveri N. Ultrasound M-mode assessment of diaphragmatic kinetics by anterior transverse scanning in healthy subjects. Ultrasound Med Biol. 2011 Jan;37(1):44-52. doi: 10.1016/j.ultrasmedbio.2010.10.004. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Respiratory pattern variables | Respiratory pattern variables will be measured by the Respiratory Diagnostic Assistant.
The algorithm of the "Respiratory Diagnostic Assistant" device relates the variables respiratory rate, tidal volume, minute volume, inspiratory flow, expiratory flow, relationship between inspiratory and expiratory times. Data are given in: Respiratory rate in incursion per minute Tidal volume (measured in liters) Minute volume (measured in liters); Inspiratory flow (measured in liters); Expiratory flow (measured in liters); Ti/Ttotal, (measured in seconds) I:E, relationship between inspiratory and expiratory times Volume vs time; Flow vs time. |
Not later than 12 months after primary completion date | |
Other | Frequency of normal and altered breathing patterns | The frequency of normal and altered breathing patterns will be measured by the Respiratory Diagnostic Assistant.
The "Respiratory Diagnosis Assistant" algorithm provides the classification of the diagnosis of breathing patterns as normal or altered, considering the input variables of flow, volume and time. The normal breathing pattern described in the frequency of cases is when there is no change assessed by the algorithm. The altered breathing pattern described in the frequency of cases are changes in the breathing pattern variables captured by the device's flow sensor during breathing at rest. Data are given in: • Absolut and relative frequencies |
Not later than 12 months after primary completion date | |
Other | Lung function measured by Spirometry | Lung function tests are performed by the callibrated spirometer following American Thoracic Society guidelines (2019).
The analysis variables will be: Forced vital capacity (FVC) - given in liters and percentage of predicted value Forced expiratory volume in 1 second - (FEV1) - given in liters and percentage of predicted value Relationship between FVC/FEV1 - given in measured value and percentage of predicted value Furthermore, it allows you to draw up a functional diagnosis: Normal Obstructive ventilatory disorder (mild, moderate or severe) Restrictive ventilatory disorder (mild, moderate or severe) Mixed ventilatory disorder (with detection of obstructive and restrictive abnormality) Data are given in: Percentages |
Not later than 12 months after primary completion date | |
Other | Lung volumes at rest breathing | Lung volumes at rest breathing will be measured by calibrated ventilometer (Ferraris Mark 8 Wright Respirometer®,. United Kingdom).
Tidal volume (Vt) will be obtained by the ratio between minute volume (MV) and the respiratory rate (RR) observed during one minute of breathing at rest (Vt = MV/RR) Data are given in: Minute volume (MV) measured in liters per minute; Tidal volume (TV), measured in liters. |
Not later than 12 months after primary completion date | |
Other | Lung capacities | Lung capacities will be measured by calibrated ventilometer (Ferraris Mark 8 Wright Respirometer®,. United Kingdom).
Inspiratory capacity (IC) - It's the maximum volume voluntarily inspired from the end of a spontaneous expiration (from the resting expiratory level). Slow vital capacity (SVC) - measurement taken slowly, starting from a position of full inspiration for complete exhalation. Data are given in: Inspiratory capacity - measured in liters Slow vital capacity - measured in liters |
Not later than 12 months after primary completion date | |
Other | Maximum inspiratory pressure (MIP) | Measurement of the maximum static inspiratory pressure that a subject can generate at the mouth measuring inspiratory muscle strength measured by digital manometer (MVD300u, Homed, Brazil)
Maximum inspiratory pressure (measured in cmH2O) Maximum predicted inspiratory pressure (predicted %) - MIP predicted =63,27-0,55 (age)+17,96 (sex)+0,58 (weight ) Data are given in: CmH2O percentage of predicted value |
Not later than 12 months after primary completion date | |
Other | Maximum expiratory pressure (MEP) | Measurement of the maximum static expiratory pressure that a subject can generate at the mouth measuring expiratory muscle strength measured by digital manometer (MVD300u, Homed, Brazil)
Maximum expiratory pressure (cmH2O) Maximum predicted expiratory pressure (predicted %) MEP =-61,41+2,29 (age)-0,03 age2)+33,72 (sex)+1,40 (waist) Data are given in: CmH2O percentage of predicted value |
Not later than 12 months after primary completion date | |
Primary | Change in end-expiratory lung impedance (Delta EELZ) | Lung aeration will be assessed using Electrical Impedance Tomography (EIT). Regional EELZ will be calculated and analyzed concerning intervention times.
The change in aeration distribution or change in end-expiratory lung impedance (Delta EELZ) will be determined by comparing pre- and post-intervention EELZ for lung quadrants and dependent/non-dependent regions in each intervention. End-expiratory lung impedance (EELZ) represents the sum of the end-expiratory impedance values of the pixels in a given region of interest. Regions of interest include: right anterior, left anterior, right posterior and left posterior, and functionally, dependent or non-dependent lung. Continuous EIT monitoring will occur, and outcomes will be assessed before and after each intervention, each lasting five minutes. Data are given in: arbitrary units (a.u.) mililiters percentages |
Not later than 12 months after primary completion date | |
Primary | Change in distribution of lung ventilation (Delta Z) | The distribution of lung ventilation will also be assessed using electrical impedance tomography.
The impedance variation (Delta Z) represents the sum of the impedance values of the pixels in a given region of interest. Regions of interest include: right anterior, left anterior, right posterior and left posterior, and functionally, dependent or non-dependent lung. The change in distribution of lung ventilation will be obtained by the difference between the Delta Z before and after each intervention, comparing the measurements of the lung quadrants and in the dependent and non-dependent lung regions for each intervention. Continuous EIT monitoring will occur, and outcomes will be assessed before and after each intervention, each lasting five minutes. Data are given in: arbitrary units (a.u.) mililiters percentages |
Not later than 12 months after primary completion date | |
Secondary | Difference in diaphragmatic mobility measured by ultrasound between the supine and body lateralization positions. | Diaphragmatic mobility will be evaluated in the supine position and in the body lateralization position during the intervention using ultrasound, according to protocol from TESTA, A. et al 2011.
Measurements will be carried out with the patient breathing spontaneously in supine and body lateralization position at 30º. Data are given in: • Millimeters. |
Not later than 12 months after primary completion date |
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