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

Primary Purpose

Pneumonia

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
PEP
HFOO
Assisted Coughing
Sponsored by
Hospital Sirio-Libanes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia

Eligibility Criteria

3 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital são Luiz Jabaquara

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

HFOO

Assisted Coughing

PEP

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 11, 2014
Last Updated
February 22, 2017
Sponsor
Hospital Sirio-Libanes
Collaborators
University of Nove de Julho, Hospital e maternidade São Luiz
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1. Study Identification

Unique Protocol Identification Number
NCT02192268
Brief Title
Assesment of the Effectiveness of High Frequency Oral Oscillation and Mask of PEP in Children With Pneumonia
Acronym
PEP/HFOO
Official Title
ASSESSMENT OF THE EFFECTIVENESS OF HIGH FREQUENCY ORAL OSCILLATION AND MASK OF PEP IN CHILDREN WITH PNEUMONIA
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Sirio-Libanes
Collaborators
University of Nove de Julho, Hospital e maternidade São Luiz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HFOO
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Assisted Coughing
Arm Type
Active Comparator
Arm Description
The children in the control group will be subjected to two daily sessions of assisted coughing.
Arm Title
PEP
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PEP
Intervention Type
Other
Intervention Name(s)
HFOO
Intervention Type
Other
Intervention Name(s)
Assisted Coughing
Primary Outcome Measure Information:
Title
Change in Severity Score
Description
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.
Time Frame
Change from Baseline Severity score at 4 days
Secondary Outcome Measure Information:
Title
Change in Peak Flow meter
Description
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.
Time Frame
Change from Baseline peak flow at 4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evelim LFD Gomes, PhD
Phone
551136242572
Email
evelimfreitas@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evelim FD Gomes, PhD
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital são Luiz Jabaquara
City
São Paulo
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evelim FD Gomes, PhD
Phone
551136242572
First Name & Middle Initial & Last Name & Degree
Evelim FD Gomes, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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