Clinical trial NCT02192268: Assesment of the Effectiveness of High Frequency Oral Oscillation and Mask of PEP in Children With Pneumonia
Official title: ASSESSMENT OF THE EFFECTIVENESS OF HIGH FREQUENCY ORAL OSCILLATION AND MASK OF PEP IN CHILDREN WITH PNEUMONIA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pneumonia
Lead sponsor: Hospital Sirio-Libanes
Sponsor class: OTHER
Collaborators: name: University of Nove de Julho
name: Hospital e maternidade São Luiz
First posted: 2014-07-16
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* dyspnea
* do not agree with research

Primary outcomes:
measure: Change in Severity Score
timeFrame: Change from Baseline Severity score at 4 days
Secondary outcomes:
measure: Change in Peak Flow meter
timeFrame: Change from Baseline peak flow at 4 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital são Luiz Jabaquara
Study officials:
affiliation: University of Nove de Julho
name: Evelim FD Gomes, PhD
role: PRINCIPAL_INVESTIGATOR
References: