Assesment of the Effectiveness of High Frequency Oral Oscillation and Mask of PEP in Children With Pneumonia (PEP/HFOO)

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

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.

Study Overview

• Status: Unknown
• Conditions: Pneumonia
• Intervention / Treatment: Other: PEP; Other: HFOO; Other: Assisted Coughing

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Hospital Sao Luiz Jabaquara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: HFOO
Active Comparator: Assisted Coughing; The children in the control group will be subjected to two daily sessions of assisted coughing.	Other: Assisted Coughing
Active Comparator: 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.	Other: PEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Severity Score	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.	Change from Baseline Severity score at 4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Peak Flow meter	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.	Change from Baseline peak flow at 4 days

Collaborators and Investigators

• Sponsor: Hospital Sirio-Libanes
• Collaborators: University of Nove de Julho; Hospital e maternidade São Luiz
• Investigators: Principal Investigator: Evelim FD Gomes, PhD, University of Nove de Julho

Study record dates

Study Major Dates

• Study Start: August 1, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: July 11, 2014
• First Submitted That Met QC Criteria: July 15, 2014
• First Posted (Estimate): July 16, 2014

Study Record Updates

• Last Update Posted (Actual): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: PEP/HFOO