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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT06154876
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
22.4
Actual Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Cough assist device
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
AssignmentAssignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect Of Cough Assist Device On Hemodynamic Status And Oxygen Saturation For Ventilated Children
Actual Study Start Date :
Dec 1, 2021
Actual Primary Completion Date :
Sep 30, 2023
Actual Study Completion Date :
Oct 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.
Other Names:
  • Designed chest physical therapy

    		•
    Active Comparator: Designed chest physical therapy

    Percussion, vibration, end expiratory pressure and bed mobility exercise.

    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.
    Other Names:
  • Designed chest physical therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 9 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo University Cairo Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Nour Reda, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nour Reda Abdelmonem Hafez, Principal investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT06154876
    Other Study ID Numbers:
    • P.T.REC./012/003526
    First Posted:
    Dec 4, 2023
    Last Update Posted:
    Dec 4, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pneumonia

    Study Results

    No Results Posted as of Dec 4, 2023