Comparative Analysis of Non-invasive Ventilatory Support Modes: High Flow Nasal Cannula and Non-invasive Ventilation in Acute Asthmatic Children
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Suplemental Oxigen day use
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The outcome accessor and the investigator when evaluating the child and the spreadsheet data will not know which therapy the patient was submitted to.
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Having associated heart disease;
- •neurological/cognitive impairment;
- •Have severe respiratory insufficiency detected by severity scores;
- •Intolerance to any type of treatment
研究组 & 干预措施
High Flow nasal cannula
It will be administered as part of the high-flow nasal cannula treatment to reduce the symptoms of acute asthma
干预措施: High Flow Nasal cannula (Other)
NIV noninvasive ventilation
It will be administered as part of the Noninvasive ventilation treatment to reduce the symptoms of acute asthma
干预措施: NIV Noninvasive Ventilation (Other)
结局指标
主要结局
Suplemental Oxigen day use
时间窗: Change from baseline Oxygen dose at first 45 minutes and 5th day in hospital.
Oxigen dose number of days used
PAS Pediatric Asthma Score
时间窗: 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.
次要结局
- Forced Expiratory volume in first second(Change from baseline FEV1 at first 45 minutes and 5th day in hospital.)
- Bronchodilator doses ( Salbutamol)(Change from baseline Salbutamol dose (First day and 5th day in hospital))
研究者
Evelim Leal de Freitas Dantas Gomes, PT
Professor
University of Nove de Julho