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Effect of Thoracic Block Technique on Arterial Blood Gases in Children With Atelectasis on Mechanical Ventilation

Primary Purpose

Atelectasis, Intensive Care Unit, Children

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Thoracic block technique
Designed chest physical therapy program
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atelectasis

Eligibility Criteria

4 Months - 4 Years (Child)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Thoracic block technique and designed chest physical therapy program

Designed chest physical therapy program

Arm Description

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

Percussion, vibration and modified postural drainage for 30 minutes every day for ten days

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Full Information

First Posted
March 25, 2023
Last Updated
July 31, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05821998
Brief Title
Effect of Thoracic Block Technique on Arterial Blood Gases in Children With Atelectasis on Mechanical Ventilation
Official Title
Effect of Thoracic Block Technique on Arterial Blood Gases, Vital Signs and Lung Compliance in Children With Atelectasis on Mechanical Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
May 25, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis, Intensive Care Unit, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thoracic block technique and designed chest physical therapy program
Arm Type
Experimental
Arm Description
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
Arm Title
Designed chest physical therapy program
Arm Type
Active Comparator
Arm Description
Percussion, vibration and modified postural drainage for 30 minutes every day for ten days
Intervention Type
Other
Intervention Name(s)
Thoracic block technique
Other Intervention Name(s)
Technique of insufflation to reverse atelectasis
Intervention Description
Manual compression of the healthy lung during expiration associated with the use of invasive or non invasive mechanical ventilation
Intervention Type
Other
Intervention Name(s)
Designed chest physical therapy program
Intervention Description
Percussion, vibration and modified postural drainage
Primary Outcome Measure Information:
Title
Assessment of oxygenation status
Description
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
Time Frame
10 days for each participant
Title
Assessment of ventilation status
Description
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
Time Frame
10 days for each participant
Title
Assessment of dynamic lung compliance
Description
Assessment of change in lung compliance value during air flow which calculated automatically by mechanical ventilator, we record it before and after intervention
Time Frame
10 days for each participant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa Abdallah
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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Effect of Thoracic Block Technique on Arterial Blood Gases in Children With Atelectasis on Mechanical Ventilation

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