Effect of Thoracic Block Technique on Atelectasis in Children on Mechanical Ventilation

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.

Study Overview

• Status: Completed
• Conditions: Children; Intensive Care Unit; Atelectasis
• Intervention / Treatment: Other: Thoracic block technique; Other: Designed chest physical therapy program

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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 , postural drainage one 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 postural drainage for 30 minutes every day for ten days	Other: Designed chest physical therapy program; Percussion, vibration and postural drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Alaa Abdallah, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2021
• Primary Completion (Actual): July 10, 2022
• Study Completion (Actual): July 20, 2022

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: P. T. REC/012/003483

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No