- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05821998
Effect of Thoracic Block Technique on Arterial Blood Gases in Children With Atelectasis on Mechanical Ventilation
Effect of Thoracic Block Technique on Arterial Blood Gases, Vital Signs and Lung Compliance in Children With Atelectasis on Mechanical Ventilation
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt
- Cairo University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age range from 4 months to 4 years.
- diagnosed with pneumonia, receiving mechanical ventilation.
- start from second day of admission to intensive care unit
- have unilateral mild to moderate atelectasis according to medical referral.
- should be vitally stable during the session.
Exclusion Criteria:
The children were excluded from the study if they had one of the following:
- medically unstable ( examples: tachycardia and tachypnea)
- uncontrolled convulsion.
- rib fracture.
- pneumothorax -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Thoracic block technique and designed chest physical therapy program
Manual compression on healthy lung for 20 seconds and rest for 20 seconds, total time 20 minutes and percussion, vibration and modified postural drainage on session time for 35 minutes every day for ten days
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Manual compression of the healthy lung during expiration associated with the use of invasive or non invasive mechanical ventilation
Other Names:
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Active Comparator: Designed chest physical therapy program
Percussion, vibration and modified postural drainage for 30 minutes every day for ten days
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Percussion, vibration and modified postural drainage
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of oxygenation status
Time Frame: 10 days for each participant
|
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
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10 days for each participant
|
Assessment of ventilation status
Time Frame: 10 days for each participant
|
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
|
Assessment of dynamic lung compliance
Time Frame: 10 days for each participant
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alaa Abdallah, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P. T. REC/012/004401
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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