Physiology of Body Lateralization on Regional Lung Ventilation Study
- Conditions
- Healthy Individuals
- Interventions
- Procedure: Supine PositioningProcedure: Body Lateral Positioning
- Registration Number
- NCT06044896
- Lead Sponsor
- University of Pernambuco
- Brief Summary
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
- Detailed Description
Body positioning is a therapy used in the hospital environment to improve oxygenation. Recent studies recommend lateralization therapy to improve lung function locally by positioning the chest region of interest upwards. However, there are still gaps in the description of the effects of body lateralization on lung aeration and ventilation between non-dependent and gravity-dependent regions and on diaphragmatic mobility.
The objective of this study is to analyze the acute effects of lateralization on the aeration and distribution of lung ventilation, in comparison with the supine position, in healthy subjects. In addition, the effect of body positioning on diaphragm kinetics was evaluated.
This is a crossover study, which will be carried out at the Hospital das Clínicas of the Federal University of Pernambuco (HC-UFPE). The sample will consist of 30 healthy volunteers, aged between 18 and 59 years, of both sexes.
The change of body position will be performed using the Multicare bed (Linet, Praga,Czech Republic).
Lung ventilation and aeration will be evaluated with an Enlight 1800 electrical impedance tomography (EIT) (Timpel Medical, São Paulo, Brazil). The EIT images will be segmented into four regions of interest (ROIs: anterior right, anterior left, posterior right and posterior left. Diaphragm mobility will be quantified by diaphragmatic ultrasound in the supine and lateral positions.
The study was approved by the Research Ethics Committee of the Hospital das Clínicas of the Federal University of Pernambuco (EBSERH), in accordance with the norms of the National Health Council (Resolution 466/12) for research in human beings (opinion number 5,980.254).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Healthy individuals
- Volunteers aged between 18 and 59 years old (youth/adults)
- Volunteers of both sexes
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Supine Positioning Supine Positioning The participant will be in the supine position. Body Lateral Positioning Body Lateral Positioning The participant will be in the body lateral position at 30 degrees.
- Primary Outcome Measures
Name Time Method Change in distribution of lung ventilation (Delta Z) Not later than 12 months after primary completion date 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
* percentagesChange in end-expiratory lung impedance (Delta EELZ) Not later than 12 months after primary completion date 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
- Secondary Outcome Measures
Name Time Method Difference in diaphragmatic mobility measured by ultrasound between the supine and body lateralization positions. Not later than 12 months after primary completion date 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.
Trial Locations
- Locations (2)
Hospital das Clínicas da UFPE
🇧🇷Recife, Brazil
Shirley Campos
🇧🇷Recife, Pernambuco, Brazil