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

Not Applicable

Completed

• Conditions: Intensive Care Unit; Children; Pneumonia Childhood
• Interventions: Device: Cough assist device

• Registration Number: NCT06154876
• Lead Sponsor: Cairo University

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

Study Timeline

• Study Start: 2021-12-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-10-15
• Status Verified: 2023-11
• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-30
• Last Update Submitted: 2023-11-30
• Study First Posted: 2023-12-04
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Exclusion criteria:

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Exclusion Criteria

1. Hemodynamically unstable child.
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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Designed chest physical therapy	Cough assist device	Percussion, vibration, end expiratory pressure and bed mobility exercise.
Cough assist device and designed chest physical therapy	Cough assist device	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt