NCT04033666

Analysis of Non-invasive Ventilatory Support Modes: High Flow Nasal Cannula and Non-invasive Ventilation

Comparative Analysis of Non-invasive Ventilatory Support Modes: High Flow Nasal Cannula and Non-invasive Ventilation in Acute Asthmatic Children

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Nove de Julho · Academic / Other
• Sex: All
• Age: 5 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

This study compares two types of noninvasive treatments for asthma attacks with the objective of analyzing the efficacy of each therapy during the period of exacerbations in infants and asthmatics hospitalized.

Detailed description

A randomized clinical trial, where it will be established, treatment in hospitalized asthma patients in the infirmary and Emergency Room of the Hospital Infantil Cândido Fontoura. The children eligible for the Protocol, after signing the terms of consent and assent, will be randomized for treatment in 2 groups (GI - bilevel and GII - High Flow Nasal Cannula). After the evaluations are started: Feb1, Volume expired in the first second; Peak Flow, vital signs and calculated Pulmonary Asthma Score, Pulmonary Asthma Severity Score, Pulmonary Index Score, and therapy application. The N to be considered for the study of 20 individuals per group. Group therapy I will be applied in diaphragmatic re-education exercises 3 x 10 breaths, after non-invasive ventilation, with parameters 12 cm H2O Ipap and Epap 8 cm H2O, for 45 minutes, according to patient tolerance, interface, with full face mask After treatment, reassessment of vital signs and measurements of Peak Flow, Fev1 and Severity Scores. The GII will be established therapy with high-flow nasal cannula with dosage and cannula calculated according to the child's weight and respiratory rate at the time of evaluation, ranging from 2 l / min to 30 l / min. flow. The therapy will begin with diaphragmatic exercises 3 x 10 breaths, after 45 minutes of the installation of the therapy that is continuous, will be performed a reassessment of vital signs and Peak Flow, Feb, Severity Scores. During the hospitalization time of the child will be carried out the daily treatment, therapy chosen for each patient for 45 minutes in the case of GI and the GII group daily follow-up and adjustment of flow dosage, also evaluated the vital signs, vital signs and Peak Flow, Feb, Gravity Scores. At the time of hospital discharge, the evaluations will be performed and data such as inhaled corticosteroid use, oxygen use in days and inspired fraction, hospitalization days, hospital costs, as well as vital signs, vital signs and Peak Flow, Fev, Scores of Gravity.

Conditions

• Asthma Acute

Interventions

Type	Name	Description
OTHER	High Flow Nasal cannula	The HFNC will be instituted therapy with high-flow nasal cannula with dosage and cannula calculated according to the child's weight, ranging from 2 l / min to 30 l / min. The therapy will begin with diaphragmatic exercises 3x10 breaths and after high-flow therapy with nasal cannula for 45 minutes, after which will be performed the vital signs evaluations and Peak Flow, HRV, FEV1.
OTHER	NIV Noninvasive Ventilation	The Therapy consisted of 3x10 diaphragmatic re-education exercises after a Bipap device was coupled in bipedal mode with parameters Ipap 12 cm H2O and Epap 8 cm H2O, for 45 minutes, according to the patient's tolerance, with Full face facial mask. After therapy evaluated vital signs and measures of Peak Flow, HRV, FEV1.

Timeline

• Start date: 2019-01-10
• Primary completion: 2019-07-30
• Completion: 2019-11-30
• First posted: 2019-07-26
• Last updated: 2019-07-26

Locations

1 site across 1 country: Brazil