跳至主要内容
临床试验/NCT02192268
NCT02192268Unknown不适用

ASSESSMENT OF THE EFFECTIVENESS OF HIGH FREQUENCY ORAL OSCILLATION AND MASK OF PEP IN CHILDREN WITH PNEUMONIA

Hospital Sirio-Libanes1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Change in Severity Score

研究概览

简要总结

The hypothesis of this study is that the physiologic effects of these (PEP/ HFOO) resources may have positive effects in this population of children with acute respiratory illness.

Thinking about this physical and physiological issue and due to the absence of a study that has evaluated the effectiveness of these instruments in patients with pneumonia, the objective of this study is to evaluate the short-term effects OOAF and mask of EPAP in children hospitalized for community-acquired pneumonia.

详细描述

The pneumonia is characterized by an acute infectious and inflammatory process, usually compromises the alveoli, bronchioles and interstitial space difficulting hematosis and may be in some or all of the cells filled with liquid and blood cells. The accumulation of secretion occurs as a consequence of this infectious and inflammatory process and contributes to clinical worsening by increasing airway resistance.

Respiratory physiotherapy has been questioned in patients with pneumonia and recent clinical studies have shown that there is no benefit to these patients. Respiratory physical therapy in addition to manual techniques has in his repertoire instrumental resources such as therapeutic high-frequency oral oscillator (HFOO) and the mask of expiratory positive pressure (PEP). The hypothesis of this study is that physical and physiological effects of these resources may have positive effects in this population of children with acute respiratory illness. The aim of this study is to evaluate the short-term effects HFOO and mask of PEP in children hospitalized for community-acquired pneumonia.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • age between 03 and 11 years old;
  • have Pneumonia diagnosis done by a physician pediatrician (1) presence of cough and/or fever; (2) tachypnea according to age group (1-5 years-40 bpm; 5 years -30 bpm); (3) radiological change with consolidation or infiltrators associated or not with other findings compatible with pneumonia. All films will be evaluated by a radiologist and a pediatrician

排除标准

  • chronic neurological Disease, or respiratory arrest
  • failure to collaborate with therapy or assessment
  • need of invasive or non-invasive ventilatory assistance
  • hemodynamic instability
  • vomiting or nausea
  • not drained Pneumothorax
  • not drained extensive pleural effusion
  • do not agree with research

结局指标

主要结局

Change in Severity Score

时间窗: Change from Baseline Severity score at 4 days

Will be assigned a severity score proposed based on other studies with clinical variables and diagnostic criteria. This score will vary from 0 to 18 points. Participants will be followed for the duration of hospital stay, an expected average of 4 or 5 days.

次要结局

  • Change in Peak Flow meter(Change from Baseline peak flow at 4 days)

研究者

发起方
Hospital Sirio-Libanes
申办方类型
Other
责任方
Principal Investigator
主要研究者

Evelim Leal de Freitas Dantas Gomes, PhD

PhD

Hospital Sirio-Libanes

研究点 (1)

Loading locations...

相似试验

Assesment of the Effectiveness of High Frequency... | 临床试验