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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT05480202

Collaborator

(none)

Enrollment

Location

Arms

7.4

Actual Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atelectasis Intensive Care Unit Children	Other: Thoracic block technique Other: Designed chest physical therapy program	N/A

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:

age range from 6 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.

B. Exclusion criteria:

The children will be excluded from the study if they had one of the following:

medically unstable ( examples: tachycardia and tachypnea).
uncontrolled convulsion.
irritable or moderate to sever pain
rib fracture
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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 6, 2021

Actual Primary Completion Date :

Jul 10, 2022

Actual Study Completion Date :

Jul 20, 2022

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 , 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

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

Outcome Measures

Primary Outcome Measures

Assessment of heart rate and respiratory rate [10 days for each participant]
Assessment of change in heart rate and respiratory rate will be carried out by using electro cardiograph electrodes and pulse oximeter.
Assessment of atelectasis in chest x ray [10 days for each participant]
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
Assessment of arterial blood gases test [10 days for each participant]
Assessment of change in arterial blood gases test will be carried out by comparing results before and after intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 4 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age range from 6 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.

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:

medically unstable ( examples: tachycardia and tachypnea).
uncontrolled convulsion.
irritable or moderate to sever pain
rib fracture
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:

NCT05480202

Other Study ID Numbers:

P. T. REC/012/003483

First Posted:

Jul 29, 2022

Last Update Posted:

Jul 29, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pulmonary Atelectasis

Study Results

No Results Posted as of Jul 29, 2022