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

NCT06384027 | Completed

• 1 other identifier: VNI_USG_2024
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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

Keywords

Non-invasive ventilation; Diaphragmatic ultrasound; Inferior vena cava

Outcome Measures

Primary Outcomes (1)

• Diaphragmatic thickening fraction

  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

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

Secondary Outcomes (1)

• Diaphragmatic mobility

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

Other Outcomes (1)

• Ultrasound of inferior vena cava distension

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

Study Arms (3)

Spontaneous breathing

NO INTERVENTION

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.

CPAP

ACTIVE COMPARATOR

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.

Other: Non-invasive ventilation

Bilevel

ACTIVE COMPARATOR

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.

Other: Non-invasive ventilation

Interventions

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).

Bilevel; CPAP

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Paraíba: lead

Study Sites (1)

Federal University of Paraiba

João Pessoa, Paraíba, 58051-900, Brazil

Location

Related Publications (1)

• 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.

  PMID: 34473571 BACKGROUND

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: This is a crossover, randomized study, blinded

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 25, 2024
• Study Start: April 24, 2024
• Primary Completion: July 21, 2024
• Study Completion: July 21, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)