Effect Of Cough Assist Device On Hemodynamic Status And Oxygen Saturation For Ventilated Children
NCT ID: NCT06154876
Last Updated: 2023-12-04
Study Results
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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COMPLETED
NA
50 participants
INTERVENTIONAL
2021-12-01
2023-10-15
Brief Summary
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•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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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cough assist device and designed chest physical therapy
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.
Cough assist device
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.
Designed chest physical therapy
Percussion, vibration, end expiratory pressure and bed mobility exercise.
Cough assist device
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.
Interventions
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Cough assist device
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Children will diagnosed with pneumonia.
3. Children will intubated on mechanical ventilation.
4. All children should be vitally stable during the study period.
Exclusion Criteria
2. Child with diaphragmatic hernia.
3. Child with pneumothorax (if chest tube is present).
4. Child with raised intracranial pressure.
5. Child with recent upper Gastrointestinal surgery
4 Years
9 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Nour Reda Abdelmonem Hafez
Principal investigator
Principal Investigators
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Nour Reda
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
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Cairo University
Cairo, , Egypt
Countries
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Other Identifiers
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P.T.REC./012/003526
Identifier Type: -
Identifier Source: org_study_id