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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05821998
Other study ID # P. T. REC/012/004401
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2022
Est. completion date May 31, 2023

Study information

Verified date July 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Statement of the problem: • Does the thoracic block technique has effect on arterial blood gases, vital signs and lung compliance in children with atelectasis on mechanical ventilation? Null hyposis there is no effect of thoracic block technique on arterial blood gases, vital signs and lung compliance in children with atelectasis on mechanical ventilation.


Description:

Subjects: The study targets the children from both sexes.diagnosed with atelectasis 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, 22 child received percussion, vibration, modified postural drainage and the other 22 child will receive percussion, vibration, modified postural drainage and thoracic block technique. Children will be assessed by measuring heart rate, respiratory rate,which reflect the physiological status, arterial blood gases which include partial pressure of oxygen (PaO2), partial pressure of carbon dioxide (PaCO2) and oxygen saturation (SaO2) and dynamic lung compliance which reflect clinical improvement of chest condition before and after ten days of receiving intervention


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date May 31, 2023
Est. primary completion date May 25, 2023
Accepts healthy volunteers No
Gender All
Age group 4 Months to 4 Years
Eligibility Inclusion Criteria: 1. age range from 4 months to 4 years. 2. diagnosed with pneumonia, receiving mechanical ventilation. 3. start from second day of admission to intensive care unit 4. have unilateral mild to moderate atelectasis according to medical referral. 5. should be vitally stable during the session. Exclusion Criteria: The children were excluded from the study if they had one of the following: 1. medically unstable ( examples: tachycardia and tachypnea) 2. uncontrolled convulsion. 3. rib fracture. 4. pneumothorax -

Study Design


Intervention

Other:
Thoracic block technique
Manual compression of the healthy lung during expiration associated with the use of invasive or non invasive mechanical ventilation
Designed chest physical therapy program
Percussion, vibration and modified postural drainage

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 oxygenation status Assessment of change of partial pressure of arterial oxygen which is one value in arterial blood gases test results which calculated by arterial blood gases analyzier and comparing results before and after intervention 10 days for each participant
Primary Assessment of ventilation status Assessment of change of partial pressure of carbon dioxide which is one value of arterial blood gases test results and calculated by arterial blood gases analyzier before and after intervention 10 days for each participant
Primary Assessment of dynamic lung compliance Assessment of change in lung compliance value during air flow which calculated automatically by mechanical ventilator, we record it before and after intervention 10 days for each participant
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