Physiology of Body Lateralization on Regional Lung Ventilation Study

NCT06044896 | Completed

• 1 other identifier: UFPE 5.980.254
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Conditions

Healthy Individuals

Keywords

Healthy Volunteers; Patient Positioning; Pulmonary Ventilation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Difference in diaphragmatic mobility measured by ultrasound between the supine and body lateralization positions.

  Not later than 12 months after primary completion date

Other Outcomes (7)

• Respiratory pattern variables

  Not later than 12 months after primary completion date

• Frequency of normal and altered breathing patterns

  Not later than 12 months after primary completion date

• Lung function measured by Spirometry

  Not later than 12 months after primary completion date

Study Arms (2)

Supine Positioning

EXPERIMENTAL

The participant will be in the supine position.

Procedure: Supine Positioning

Body Lateral Positioning

EXPERIMENTAL

The participant will be in the body lateral position at 30 degrees.

Procedure: Body Lateral Positioning

Interventions

Supine Positioning PROCEDURE

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.

Also known as: Supine Position, Supine

Supine Positioning

Body Lateral Positioning PROCEDURE

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.

Also known as: 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

Body Lateral Positioning

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Pernambuco: collaborator
• University of Pernambuco: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Fundação de Amparo à Ciência e Tecnologia de Pernambuco: collaborator
• Coordination for the Improvement of Higher Education Personnel: collaborator

Study Sites (2)

Shirley Campos

Recife, Pernambuco, 50740-600, Brazil

Location

Hospital das Clínicas da UFPE

Recife, Brazil

Location

Related Publications (4)

• 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.

  PMID: 12186831 BACKGROUND

• 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.

  PMID: 21144957 BACKGROUND

• 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.

  PMID: 30956204 BACKGROUND

• 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.

  PMID: 41166369 DERIVED

MeSH Terms

Interventions

Supine Position

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Layane Santana

  University of Pernambuco

  STUDY DIRECTOR

• Shirley Campos

  University of Pernambuco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Researcher

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 21, 2023
• Study Start: September 22, 2023
• Primary Completion: October 25, 2023
• Study Completion: October 25, 2023
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Through study completion, an average of 1 year.
• Access Criteria: Individual participant data (IPD) access will be granted by the PI after request review for approval via email. It will be shared with researchers and general public of interest on the subject for descriptive analyses related to our sample. A committee of researchers will be in charge of discussing the request before approving the access.

Locations

BR (2)