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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04033666
Enrollment
50
Registered
2019-07-26
Start date
2019-01-10
Completion date
2019-11-30
Last updated
2019-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma Acute

Keywords

asthma, High flow nasal cannula, Non invasive ventilation

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.

Interventions

OTHERHigh 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.

OTHERNIV 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.

Sponsors

University of Nove de Julho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

The outcome accessor and the investigator when evaluating the child and the spreadsheet data will not know which therapy the patient was submitted to.

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

Eligibility

Sex/Gender
ALL
Age
5 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PAS Pediatric Asthma ScoreChange from baseline PAS at first 45 minutes and 5th day in hospitalPAS 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.
Suplemental Oxigen day useChange from baseline Oxygen dose at first 45 minutes and 5th day in hospital.Oxigen dose number of days used

Secondary

MeasureTime frameDescription
Forced Expiratory volume in first secondChange 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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026