Physiology of Body Lateralization on Regional Lung Ventilation Study
Condition: Healthy Individuals
Study type: Interventional

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).
    

Intervention name(s): Supine Positioning; Body Lateral Positioning
Intervention type(s): Procedure; Procedure
Intervention description(s): The participant will be guided to the Multicare bed and will be positioned supine with the headboard not tilted. At this point, the participant will already have the EIT electrode belt and head, trunk and lower limb cushions around it, providing stability. After the participant has been correctly positioned, ventilatory monitoring will begin using the EIT. The environment must be fully controlled, that is, with adequate lighting, all collection members in silence, as well as the devices in the place, air-conditioned environment, without exposing the participant to heat or cold. Before starting the collection, the volunteer will be asked to try not to sleep or talk, making it clear that any discomfort can be reported at any time. To keep the volunteer awake, visual and sound stimuli can be performed. Furthermore, if you cough or sigh, the collection will restart. The intervention will last 5 minutes and will be repeated twice, with intervals between body lateralization.; The participant will start from the bench press to the 30-degree lateral position. The cushions placed at the beginning of the collection will provide stability so that the inclination does not compromise the correct positioning of the participant, preventing them from sliding on the bed. Furthermore, it is also a safety measure for the participant. The environment will be controlled throughout the intervention and visual and sound effects will also be performed in lateral positioning. The volunteer will remain in this position for five minutes and shortly after will be placed in the supine position again. To start the protocol for the second and final time, the participant will have a washout time of thirty minutes.
Other intervention name(s): Supine Position; Supine; Automatic patient positioning; Continuous lateral rotation therapy; Lateral rotation therapy; Continuous rotational therapy; Kinetic bed therapy; Lateral change Positioning; Automated lateral rotation; Rotating bed; Automatic lateral therapy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Healthy Volunteers; Patient Positioning; Pulmonary Ventilation