Physiology of Body Lateralization on Regional Lung Ventilation Study

NCT06044896 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-10-27

No results posted yet for this study

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

Interventions

PROCEDURE

Supine Positioning

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.

PROCEDURE

Body Lateral Positioning

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.

Sponsors & Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV
  • Fundação de Amparo à Ciência e Tecnologia de Pernambuco

    collaborator OTHER
  • Coordination for the Improvement of Higher Education Personnel

    collaborator OTHER
  • Universidade Federal de Pernambuco

    collaborator OTHER
  • University of Pernambuco

    lead OTHER

Principal Investigators

  • Layane Santana · University of Pernambuco

  • Shirley Campos · University of Pernambuco

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-22
Primary Completion
2023-10-25
Completion
2023-10-25

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06044896 on ClinicalTrials.gov