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

NCT ID: NCT06384027

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-24
• Study Completion Date: 2024-07-21

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Spontaneous breathing

The volunteer will remain lying down for a period of 5 minutes in spontaneous breathing and after this period the diaphragmatic and inferior vena cava ultrasound outcomes will be evaluated.

Group Type: NO_INTERVENTION

No interventions assigned to this group

CPAP

When using CPAP, these same outcomes will be evaluated at three different PEEP levels, namely: 5, 10 and 15 cmH2O after 5 minutes of use.

Group Type: ACTIVE_COMPARATOR

Non-invasive ventilation

Intervention Type: 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).

Bilevel

During the use of Bi-level, we will maintain the PEEP value at 5cmH2O and modify the pressure support (PS) ventilation values, establishing the following values: 5, 7 and 10 cmH2O of PS, with all outcomes also being evaluated at the same time. end of 5 minutes.

Group Type: ACTIVE_COMPARATOR

Non-invasive ventilation

Intervention Type: 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).

Interventions

Non-invasive ventilation

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).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Paraíba

OTHER

Sponsor Role: lead

Responsible Party

Eduardo Eriko Tenório de França

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federal University of Paraiba

João Pessoa, Paraíba, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 34473571 (View on PubMed)

Other Identifiers

VNI_USG_2024

Identifier Type: -

Identifier Source: org_study_id