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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06154876
Enrollment
50
Registered
2023-12-04
Start date
2021-12-01
Completion date
2023-10-15
Last updated
2023-12-04

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

Conditions

Children, Intensive Care Unit, Pneumonia Childhood

Brief summary

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

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

Interventions

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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

Assignment

Eligibility

Sex/Gender
ALL
Age
4 Years to 9 Years
Healthy volunteers
No

Inclusion criteria

1. Children of both sexes, with age ranged from 4-9 years old. 2. Children will diagnosed with pneumonia. 3. Children will intubated on mechanical ventilation. 4. All children should be vitally stable during the study period.

Design outcomes

Primary

MeasureTime frameDescription
Assessment of oxygen saturation14 days for each participant or time of weaningPulse oximeter attached to the child and recorded oxygen saturation before and after intervention.
Assessment of expired Tidal Volume14 days for each participant or time of weaningExpired Tidal volume recorded from mechanical ventilation attached to the child before and after intervention

Countries

Egypt

Outcome results

None listed

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