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

Pneumonia Clinical Trial

— PEP/HFOO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02192268
• Other study ID #: PEP/HFOO
• Status: Not yet recruiting
• Phase: N/A
• First received: July 11, 2014
• Last updated: February 22, 2017
• Start date: August 1, 2017
• Est. completion date: January 2018

Study information

• Verified date: February 2017
• Source: Hospital Sirio-Libanes
• Contact: Evelim LFD Gomes, PhD
• Phone: 551136242572
• Email: evelimfreitas[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia

Intervention

Other:
• PEP

• HFOO

• Assisted Coughing

Locations

Country	Name	City	State
Brazil	Hospital são Luiz Jabaquara	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Sirio-Libanes	Hospital e maternidade São Luiz, University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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