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

NCT ID: NCT05480202

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-06

Study Completion Date

2022-07-20

Brief Summary

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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.

Detailed Description

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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

Conditions

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Atelectasis Intensive Care Unit Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Thoracic block technique

Intervention Type OTHER

Manual compression of the healthy lung during expiration associated with the use of invasive or non invasive mechanical ventilation

Designed chest physical therapy program

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

Group Type ACTIVE_COMPARATOR

Designed chest physical therapy program

Intervention Type OTHER

Percussion, vibration and postural drainage

Interventions

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Thoracic block technique

Manual compression of the healthy lung during expiration associated with the use of invasive or non invasive mechanical ventilation

Intervention Type OTHER

Designed chest physical therapy program

Percussion, vibration and postural drainage

Intervention Type OTHER

Other Intervention Names

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Technique of insufflation to reverse atelectasis

Eligibility Criteria

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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.

Exclusion Criteria

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


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
Minimum Eligible Age

6 Months

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Alaa Abdallah Amin

Scientific researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alaa Abdallah

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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P. T. REC/012/003483

Identifier Type: -

Identifier Source: org_study_id