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Clinical Trials/NCT06384027
NCT06384027
Recruiting
Not Applicable

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

Federal University of Paraíba1 site in 1 country100 target enrollmentFebruary 5, 2024
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Federal University of Paraíba
Enrollment
100
Locations
1
Primary Endpoint
Diaphragmatic thickening fraction
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 5, 2024
End Date
June 10, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Federal University of Paraíba
Responsible Party
Principal Investigator
Principal Investigator

Eduardo Eriko Tenório de França

Clinical Professor

Federal University of Paraíba

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.

Outcomes

Primary Outcomes

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

  • Diaphragmatic mobility(The assessment will be carried out after 5 minutes of RE, CPAP or Bilevel)

Study Sites (1)

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