Skip to main content
OpenTrials
Completed

NCT Number: NCT06384027

Effects of Non-invasive Ventilation on Function Diaphragmatic and Caval Distension

Introduction: Understanding how the applicability of non-invasive ventilation can directly affect the anatomy and diaphragmatic function, as well as the opening diameter of the inferior vena cava in healthy individuals is fundamental to knowing how this therapy can interfere with treatment results. Objective: Identify the acute effects of PEEP and ventilatory support pressure on thickening fraction, diaphragmatic mobility and vena cava distension in healthy people. Methods: This is a crossover, randomized study, blinded to the evaluator and the researcher responsible for the statistical analysis. Volunteers will undergo a NIV session, randomized into groups: CPAP, Bi-level and spontaneous breathing, without NIV support (control). The outcomes evaluated will be diaphragmatic ultrasound and inferior vena cava distensibility. The CPAP levels will be: 5, 10 and 15 cmH2O after 5 minutes of use and in the Bi-level group we will maintain the PEEP value at 5cmH2O and modify the pressure support values to the values: 5, 7 and 10 cmH2O pressure support, with all outcomes also being assessed after 5 minutes. Participants will remain in a supine position, with the right upper limb positioned behind the head, throughout the protocol and all measurements will be collected in the inspiratory and expiratory phases with volumes basal currents. For statistical analysis, intention-to-treat analysis will be employed and groups will be compared using Student's t-test, for continuous variables, or chi-square, for categorical variables. ANOVA split-plot, repeated measures for primary occurrences. Analyzes of covariance to identify differences between groups using baseline scores as covariates. Effect sizes and confidence intervals will be calculated using eta squared (η²). Expected results: Elucidate the effects of different blood pressure levels on diaphragmatic function and inferior vena cava distension.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Paraiba

João Pessoa, Paraíba, 58051-900, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers;
  • Age equal to or over 18 years old and under 50 years old.

Exclusion criteria

  • Cardiopathy;
  • Pneumopathy;
  • Participants who develop any disabling condition that prevents completion of the protocol.

Treatment and study plan

Non-invasive ventilation

Other

Ventilation support that does not require an artificial airway that aims to reverse respiratory muscle fatigue and decrease the work of the respiratory muscles, maintaining a positive pressure, allows alveolar recruitment, preventing atelectasis and airway collapse. NIV can be administered using continuous positive airway pressure (CPAP) or two levels of airway pressure (Bi-level).

Primary outcomes

  1. Diaphragmatic thickening fraction

    Time frame: The assessment will be carried out after 5 minutes of RE, CPAP or Bilevel

    Diaphragmatic ultrasound is a useful technique for evaluating diaphragm function. To evaluate atrophy, it will be necessary to evaluate the thickening fraction (EF). A high-frequency linear transducer (7-13 MHz) will be placed over the ZA, between the eighth and ninth intercostal space, usually 0.5-2.0 cm below the costophrenic angle, between the anterior axillary line and the axillary line. medium, at a depth of 1.5 to 3 cm. The thickening fraction will be measured from the center of the pleural line to the center of the peritoneal line, at the end of expiration (Tdi-exp) and then at the end of inspiration (Tdi-insp), in modes B and M. calculated as follows:

    FE = Tdi-insp - Tdi-exp × 100 Tdi-exp

Secondary outcomes

  1. Diaphragmatic mobility

    Time frame: The assessment will be carried out after 5 minutes of RE, CPAP or Bilevel

    Diaphragmatic mobility (MD) is measured by visualizing the hemidiaphragms through the anterior subcostal route with the convex probe below the costal margin between the midclavicular line and the anterior axillary line, the ultrasound shows the diaphragm as a deep curved structure that separates the thorax from the abdomen. To quantify mobility and diaphragmatic thickening objectively, it is necessary to evaluate at least three images and calculate the average of the MD and FE values. During the assessments, we visualize the MD during calm breathing.

Other outcomes

  1. Ultrasound of inferior vena cava distension

    Time frame: The assessment will be carried out after 5 minutes of RE, CPAP or Bilevel

    The assessment of distension of the inferior vena cava is carried out with a convex transducer, in the subcostal window, below the xiphoid process, so that the evaluator monitors changes in diameter in real time, according to the participant's respiratory movements, thus evaluating the inspiratory and expiratory diameter of the inferior vena cava, which will later be analyzed to obtain the inferior vena cava collapsibility index:

    [(Maximum diameter - Minimum diameter) / Maximum diameter] X 100.

Sponsors and collaborators

Lead sponsor

Federal University of Paraíba

Other

Registry information

Official study title

Acute Effects of Non-invasive Ventilation on Muscle Function Diaphragmatic and Inferior Vena Cava Distension in People Healthy

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 25, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.