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Healthy IndividualsLATLUNGSNCT06044896

Physiology of Body Lateralization on Regional Lung Ventilation Study

A study testing Supine Positioning and Body Lateral Positioning in people with Healthy Individuals, run by University of Pernambuco at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Individuals
What is being tested?
Supine Positioning and Body Lateral Positioning
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesBrazil
Study dates
22 Sep 2023to 25 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy individuals
  • Volunteers aged between 18 and 59 years old (youth/adults)
  • Volunteers of both sexes

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • Shirley Campos

    Recife, Pernambuco, 50740-600

  • Hospital das Clínicas da UFPE

    Recife

Other trials in Brazil

About this study

Official title: Physiological Effects of Lateral Body Positioning on Regional Ventilation and Ultrasound Diaphragmatic Mobility in Healthy Subjects: an Experimental Study

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:

Read more
  • 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
Read the 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).

Being tested
Supine Positioning, Body Lateral Positioning
Keywords
Healthy Volunteers, Patient Positioning, Pulmonary Ventilation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supine PositioningProcedure or surgery

    Also called Supine Position, Supine

    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.

  • Body Lateral PositioningProcedure or surgery

    Also called Automatic patient positioning, Continuous lateral rotation therapy, Lateral rotation therapy, Continuous rotational therapy

    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.

Study groups in NCT06044896
Study groupRoleWhat they receive
Supine PositioningExperimentalThe participant will be in the supine position.
Receives: Procedure: Supine Positioning
Body Lateral PositioningExperimentalThe participant will be in the body lateral position at 30 degrees.
Receives: Procedure: Body Lateral Positioning

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Not later than 12 months after primary completion date

  2. 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

    Measured: Not later than 12 months after primary completion date

Secondary outcomes (1)

  1. 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.

    Measured: Not later than 12 months after primary completion date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start22 Sep 2023
  3. Primary completion25 Oct 2023
  4. Study completion25 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06044896
Sponsor's protocol ID
UFPE 5.980.254
Acronym
LATLUNGS
Status last verified
Oct 2023
First submitted
30 Aug 2023
Last updated
27 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Participant characteristics Medical history Clinical measurements Functional results Images (USG) Adverse events

Publications

  • 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.

    PubMed 12186831

  • 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.

    PubMed 21144957

  • 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.

    PubMed 30956204

  • Costa LSP, Reinaux CMA, Junior EFFS, Leite WS, Brandao DC, de Andrade AD, Roldan R, Morais CCA, Campos SL. Physiology of body lateralization on regional lung ventilation and lung volumes in healthy subjects: Within-subjects design. PLoS One. 2025 Oct 30;20(10):e0335622. doi: 10.1371/journal.pone.0335622. eCollection 2025.

    PubMed 41166369

Questions about this trial

What is this clinical trial studying?

A study testing Supine Positioning and Body Lateral Positioning in people with Healthy Individuals, run by University of Pernambuco at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in end-expiratory lung impedance (Delta EELZ) (time frame: Not later than 12 months after primary completion date). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06044896, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.

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