Clincosm LogoSign in Get a demo

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

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05821998
Collaborator
(none)
44
Enrollment
1
Location
2
Arms
4.8
Anticipated Duration (Months)
9.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Thoracic block technique
  • Other: Designed chest physical therapy program
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of Thoracic Block Technique on Arterial Blood Gases, Vital Signs and Lung Compliance in Children With Atelectasis on Mechanical Ventilation
Actual Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Apr 25, 2023
Anticipated Study Completion Date :
Apr 25, 2023

Arms and Interventions

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

Other: Thoracic block technique
Manual compression of the healthy lung during expiration associated with the use of invasive or non invasive mechanical ventilation
Other Names:
  • Technique of insufflation to reverse atelectasis

    		•
    Active Comparator: Designed chest physical therapy program

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

    Other: Designed chest physical therapy program
    Percussion, vibration and modified postural drainage

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of oxygenation status [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

    2. Assessment of ventilation status [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

    3. Assessment of dynamic lung compliance [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Months to 4 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo University Cairo Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Alaa Abdallah, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alaa Abdallah Amin, Scientific researcher, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05821998
    Other Study ID Numbers:
    • P. T. REC/012/004401
    First Posted:
    Apr 20, 2023
    Last Update Posted:
    Apr 20, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pulmonary Atelectasis

    Study Results

    No Results Posted as of Apr 20, 2023