Assesment of the Effectiveness of High Frequency Oral Oscillation and Mask of PEP in Children With Pneumonia

Not Applicable

• Conditions: Pneumonia
• Interventions: Other: HFOO; Other: Assisted Coughing; Other: PEP

• Registration Number: NCT02192268
• Lead Sponsor: Hospital Sirio-Libanes

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.

Study Timeline

• Study First Submitted: 2014-07-11
• Study First Submitted QC: 2014-07-15
• Study First Posted: 2014-07-16
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24
• Study Start: 2017-08-01
• Primary Completion: 2017-12
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HFOO	HFOO	Children of the HFOO group will be subjected to two daily sessions of this resource which should be the same throughout her hospitalization with Shaker equipment.
Assisted Coughing	Assisted Coughing	The children in the control group will be subjected to two daily sessions of assisted coughing.
PEP	PEP	The children will be subjected to PEP group two daily sessions of this resource which should be the same throughout her hospitalization with facial mask and valve Spring load with expiratory pressure of 10cmH2O.

Primary Outcome Measures

Name	Time	Method
Change in Severity Score	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.

Secondary Outcome Measures

Name	Time	Method
Change in Peak Flow meter	Change from Baseline peak flow at 4 days	Peak Flow will be held three measurements in standing position with nasal clip with MedicateTM equipment with ATS range (60 to 900lmin) adult and pediatric use. Participants will be followed for the duration of hospital stay, an expected average of 4 or 5 days.

Trial Locations

Locations (1)

Hospital são Luiz Jabaquara; 🇧🇷 São Paulo, Brazil