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

NCT ID: NCT02192268

Last Updated: 2017-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-01-31

Brief Summary

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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

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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.

Conditions

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Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

HFOO

Intervention Type OTHER

Assisted Coughing

The children in the control group will be subjected to two daily sessions of assisted coughing.

Group Type ACTIVE_COMPARATOR

Assisted Coughing

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

PEP

Intervention Type OTHER

Interventions

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PEP

Intervention Type OTHER

HFOO

Intervention Type OTHER

Assisted Coughing

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nove de Julho

OTHER

Sponsor Role collaborator

Hospital e maternidade São Luiz

UNKNOWN

Sponsor Role collaborator

Hospital Sirio-Libanes

OTHER

Sponsor Role lead

Responsible Party

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Evelim Leal de Freitas Dantas Gomes, PhD

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Evelim FD Gomes, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nove de Julho

Locations

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Hospital são Luiz Jabaquara

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Evelim LFD Gomes, PhD

Role: CONTACT

551136242572

Facility Contacts

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Evelim FD Gomes, PhD

Role: primary

551136242572

Other Identifiers

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PEP/HFOO

Identifier Type: -

Identifier Source: org_study_id

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