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

Cairo University (CU)

Status: Completed

Conditions: Children; Intensive Care Unit; Pneumonia Childhood

Treatments: Device: Cough assist device

Study type: Interventional

Funder types: Other

Identifiers

NCT06154876

P.T.REC./012/003526

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 patients

Sex: All

Ages: 4 to 9 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Cough assist device and designed chest physical therapy

Experimental group

Description:

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.

Treatment:

Device: Cough assist device

Designed chest physical therapy

Active Comparator group

Description:

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

Treatment:

Device: Cough assist device