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

Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06154876
• Other study ID #: P.T.REC./012/003526
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: October 15, 2023

Study information

• Verified date: November 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 15, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 9 Years

Eligibility

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:

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

Related Conditions & MeSH terms

• Children
• Intensive Care Unit
• Pneumonia
• Pneumonia Childhood

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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