Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384027
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2024-04-17
Brief Title:
Effects of Non-invasive Ventilation on Function Diaphragmatic and Caval Distension
Sponsor:
Federal University of Paraíba
Organization:
Federal University of Paraíba
Study Overview
Official Title:
Acute Effects of Non-invasive Ventilation on Muscle Function Diaphragmatic and Inferior Vena Cava Distension in People Healthy
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Students 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None