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

Not Applicable

• Conditions: Asthma Acute
• Interventions: Other: NIV Noninvasive Ventilation; Other: High Flow Nasal cannula

• Registration Number: NCT04033666
• Lead Sponsor: University of Nove de Julho

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.

Study Timeline

• Study Start: 2019-01-10
• Status Verified: 2019-07
• Study First Submitted: 2019-07-12
• Study First Submitted QC: 2019-07-23
• Last Update Submitted: 2019-07-23
• Study First Posted: 2019-07-26
• Last Update Posted: 2019-07-26
• Primary Completion: 2019-07-30
• Study Completion: 2019-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIV noninvasive ventilation	NIV Noninvasive Ventilation	It will be administered as part of the Noninvasive ventilation treatment to reduce the symptoms of acute asthma
High Flow nasal cannula	High Flow Nasal cannula	It will be administered as part of the high-flow nasal cannula treatment to reduce the symptoms of acute asthma

Primary Outcome Measures

Name	Time	Method
Suplemental Oxigen day use	Change from baseline Oxygen dose at first 45 minutes and 5th day in hospital.	Oxigen dose number of days used
PAS Pediatric Asthma Score	Change from baseline PAS at first 45 minutes and 5th day in hospital	PAS Pediatric Asthma Score- This score assesses respiratory distress and wheezing. Higher score the more severe the asthma attack. The score ranges from 3 to 15 and clinical improvement is expected when there is a reduction of 3 points or more.

Secondary Outcome Measures

Name	Time	Method
Forced Expiratory volume in first second	Change from baseline FEV1 at first 45 minutes and 5th day in hospital.	FEV1 liters and percentage
Bronchodilator doses ( Salbutamol)	Change from baseline Salbutamol dose (First day and 5th day in hospital)	Amount of puffs administered per day

Trial Locations

Locations (1)

Nove de Julho University; 🇧🇷 São Paulo, Brazil