Clinical trial NCT04033666: Analysis of Non-invasive Ventilatory Support Modes: High Flow Nasal Cannula and Non-invasive Ventilation
Official title: Comparative Analysis of Non-invasive Ventilatory Support Modes: High Flow Nasal Cannula and Non-invasive Ventilation in Acute Asthmatic Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma Acute
Keywords: asthma
High flow nasal cannula
Non invasive ventilation
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized clinical trial comparing high-flow nasal cannula intervention with non-invasive ventilation with two levels of pressure in children hospitalized for acute asthma
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age between 5 and 16 years;
* both genders;
* Be in the presence of the bronchospasm crisis;
* Be admitted to HICF Hospital;
* Have signed the search terms

Exclusion Criteria:

* Having associated heart disease;
* neurological/cognitive impairment;
* Have severe respiratory insufficiency detected by severity scores;
* Intolerance to any type of treatment

Primary outcomes:
measure: PAS Pediatric Asthma Score
timeFrame: Change from baseline PAS at first 45 minutes and 5th day in hospital
measure: Suplemental Oxigen day use
timeFrame: Change from baseline Oxygen dose at first 45 minutes and 5th day in hospital.
Secondary outcomes:
measure: Forced Expiratory volume in first second
timeFrame: Change from baseline FEV1 at first 45 minutes and 5th day in hospital.
measure: Bronchodilator doses ( Salbutamol)
timeFrame: Change from baseline Salbutamol dose (First day and 5th day in hospital)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Nove de Julho University
Study officials:
affiliation: University of Nove de Julho
name: Dirceu Costa
role: PRINCIPAL_INVESTIGATOR
References: