Effect Of Cough Assist Device On Hemodynamic Status And Oxygen Saturation For Ventilated Children

Study Overview
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Brief Summary
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Statement of the problem: •Is there an effect of the cough assist device on Hemodynamic status and oxygen saturation for ventilated children? Null hypothesis There will be no effect of cough assist device on hemodynamic status and oxygen saturation for ventilated children.

Detailed Description
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Subjects: The study targets the children from both sexes.diagnosed with pneumonia in intensive care unit. Sample size estimation will be carried out to determine the recruited number of children, selected randomly from Cairo University pediatric specialized hospital, Cairo to participate in the study. Study design: Randomized controlled clinical trial. Children will receive intervention type randomly,25 child will receive traditional chest physical therapy (postural drainage, percussion and vibration, end expiratory pressure) and bed mobility exercise.and the other 25 child will receive cough assist device in addition to traditional chest physical therapy (postural drainage, percussion and vibration, end expiratory pressure) and bed mobility exercise. Children will be assessed by measuring heart rate, respiratory rate, blood pressure which reflect the physiological status, oxygen saturation,expired Tidal Volume and dynamic lung compliance which reflect clinical improvement of chest condition before and after receiving intervention

Official Title
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Effect Of Cough Assist Device On Hemodynamic Status And Oxygen Saturation For Ventilated Children

Conditions
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Pneumonia Childhood, Intensive Care Unit, Children

Intervention / Treatment
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* Device: Cough assist device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children of both sexes, with age ranged from 4-9 years old. Children will diagnosed with pneumonia. Children will intubated on mechanical ventilation. All children should be vitally stable during the study period. Exclusion criteria: Exclusion Criteria: Hemodynamically unstable child. Child with diaphragmatic hernia. Child with pneumothorax (if chest tube is present). Child with raised intracranial pressure. Child with recent upper Gastrointestinal surgery

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cough assist device and designed chest physical therapy<br>Cough assist device involved 3-5 cycles with insufflation/exsufflation pressure beginning with +15 cm H2O to -15 cm H2O and maximum pressure of +40 cm H2O to -40 cm H2O for 4-5 sets for pediatric patients .and percussion, vibration, end expiratory pressure and bed mobility exercise. | Device: Cough assist device<br>* Cough assist device Cough Assist clears secretions from the lungs by gradually applying positive air pressure to the airway and then rapidly shifting to negative air pressure . The resulting high expiratory flow simulates a deep, natural cough. Designed chest physical therapy Percussion, vibration, end expiratory pressure and bed mobility exercise.<br>* Other names: Designed chest physical therapy;|
| Active Comparator: Designed chest physical therapy<br>Percussion, vibration, end expiratory pressure and bed mobility exercise. | Device: Cough assist device<br>* Cough assist device Cough Assist clears secretions from the lungs by gradually applying positive air pressure to the airway and then rapidly shifting to negative air pressure . The resulting high expiratory flow simulates a deep, natural cough. Designed chest physical therapy Percussion, vibration, end expiratory pressure and bed mobility exercise.<br>* Other names: Designed chest physical therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of oxygen saturation | Pulse oximeter attached to the child and recorded oxygen saturation before and after intervention. | 14 days for each participant or time of weaning | 
| Assessment of expired Tidal Volume | Expired Tidal volume recorded from mechanical ventilation attached to the child before and after intervention | 14 days for each participant or time of weaning |