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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02192268
Acronym
PEP/HFOO
Enrollment
30
Registered
2014-07-16
Start date
2017-08-01
Completion date
2018-01-31
Last updated
2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

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.

Interventions

OTHERPEP
OTHERHFOO
OTHERAssisted Coughing

Sponsors

University of Nove de Julho
CollaboratorOTHER
Hospital e maternidade São Luiz
CollaboratorUNKNOWN
Hospital Sirio-Libanes
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 11 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Severity ScoreChange from Baseline Severity score at 4 daysWill 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

MeasureTime frameDescription
Change in Peak Flow meterChange from Baseline peak flow at 4 daysPeak 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.

Countries

Brazil

Contacts

Primary ContactEvelim LFD Gomes, PhD
evelimfreitas@hotmail.com551136242572

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026