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Completed

NCT Number: NCT06154876

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

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.

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Key information

Age range

4 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cough assist device

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 names: Designed chest physical therapy

Primary outcomes

  1. Assessment of oxygen saturation

    Time frame: 14 days for each participant or time of weaning

    Pulse oximeter attached to the child and recorded oxygen saturation before and after intervention.

  2. Assessment of expired Tidal Volume

    Time frame: 14 days for each participant or time of weaning

    Expired Tidal volume recorded from mechanical ventilation attached to the child before and after intervention

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 4, 2023
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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