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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05480202
Other study ID # P. T. REC/012/003483
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 6, 2021
Est. completion date July 20, 2022

Study information

Verified date July 2022
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 atelectasis in Children on Mechanical Ventilation? Null hypothesis: • there is effect of thoracic block technique on atelectasis in children on Mechanical ventilation.


Description:

Subjects: The study targets the children from both sexes. Sample size estimation will be carried out to determine the recruited number of children, selected randomly from Cairo University pediatric specialized hospital intensive care units ,Cairo to participate in the study Study design: Randomized controlled clinical trial. A. Inclusion criteria: 1. age range from 6 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. B. Exclusion criteria: The children will be excluded from the study if they had one of the following: 1. medically unstable ( examples: tachycardia and tachypnea). 2. uncontrolled convulsion. 3. irritable or moderate to sever pain 4. rib fracture 5. pneumothorax Children will be assessed by measuring heart rate, respiratory rate, chest x-ray, arterial blood gases,dynamic compliance, oxygen saturation index before and after ten days of receiving intervention


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 20, 2022
Est. primary completion date July 10, 2022
Accepts healthy volunteers No
Gender All
Age group 6 Months to 4 Years
Eligibility Inclusion Criteria: 1. age range from 6 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. B. Exclusion criteria: The children were excluded from the study if they had one of the following: 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. irritable or moderate to sever pain 4. rib fracture 5. 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 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 heart rate and respiratory rate Assessment of change in heart rate and respiratory rate will be carried out by using electro cardiograph electrodes and pulse oximeter. 10 days for each participant
Primary Assessment of atelectasis in chest x ray Assessment of atelectasis in chest x ray will be carried out by comparing presence, extent and distribution of atelectasis in x ray film before and intervention 10 days for each participant
Primary Assessment of arterial blood gases test Assessment of change in arterial blood gases test will be carried out by comparing results before and after intervention 10 days for each participant
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