Clinical trial NCT06384027: Effects of Non-invasive Ventilation on Function Diaphragmatic and Caval Distension
Official title: Acute Effects of Non-invasive Ventilation on Muscle Function Diaphragmatic and Inferior Vena Cava Distension in People Healthy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Non-invasive ventilation
Diaphragmatic ultrasound
Inferior vena cava
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a crossover, randomized study, blinded
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Diaphragmatic thickening fraction
timeFrame: The assessment will be carried out after 5 minutes of RE, CPAP or Bilevel
Secondary outcomes:
measure: Diaphragmatic mobility
timeFrame: The assessment will be carried out after 5 minutes of RE, CPAP or Bilevel
Other outcomes:
measure: Ultrasound of inferior vena cava distension
timeFrame: The assessment will be carried out after 5 minutes of RE, CPAP or Bilevel
Locations:
city: João Pessoa
country: Brazil
facility: Federal University of Paraiba
state: Paraiba
Study officials:
References:
citation: Jansen D, Jonkman AH, Vries HJ, Wennen M, Elshof J, Hoofs MA, van den Berg M, Man AME, Keijzer C, Scheffer GJ, van der Hoeven JG, Girbes A, Tuinman PR, Marcus JT, Ottenheijm CAC, Heunks L. Positive end-expiratory pressure affects geometry and function of the human diaphragm. J Appl Physiol (1985). 2021 Oct 1;131(4):1328-1339. doi: 10.1152/japplphysiol.00184.2021. Epub 2021 Sep 2.