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

NCT06154876 | Completed

• 1 other identifier: P.T.REC./012/003526
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia Childhood; Intensive Care Unit; Children

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Cough assist device and designed chest physical therapy

EXPERIMENTAL

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

Designed chest physical therapy

ACTIVE COMPARATOR

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

Device: Cough assist device

Interventions

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.

Also known as: Designed chest physical therapy

Cough assist device and designed chest physical therapy; Designed chest physical therapy

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Study Officials

• Nour Reda

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Assignment

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: December 4, 2023
• Study Start: December 1, 2021
• Primary Completion: September 30, 2023
• Study Completion: October 15, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-11

Locations

EG (1)