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Clinical Trials/NCT06044896
NCT06044896CompletedNot Applicable

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

University of Pernambuco3 sites in 1 country30 target enrollmentStarted: September 22, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
3
Primary Endpoint
Change in distribution of lung ventilation (Delta Z)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to 59 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Change in distribution of lung ventilation (Delta Z)

Time Frame: 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 * percentages

Change in end-expiratory lung impedance (Delta EELZ)

Time Frame: 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 Outcomes

  • Difference in diaphragmatic mobility measured by ultrasound between the supine and body lateralization positions.(Not later than 12 months after primary completion date)

Investigators

Sponsor
University of Pernambuco
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Shirley Lima Campos

Principal Researcher

University of Pernambuco

Study Sites (3)

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