Clinical trial NCT05480202: Effect of Thoracic Block Technique on Atelectasis in Children on Mechanical Ventilation
Official title: Effect of Thoracic Block Technique on Atelectasis in Children on Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atelectasis
Intensive Care Unit
Children
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of heart rate and respiratory rate
timeFrame: 10 days for each participant
measure: Assessment of atelectasis in chest x ray
timeFrame: 10 days for each participant
measure: Assessment of arterial blood gases test
timeFrame: 10 days for each participant
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Alaa Abdallah
role: PRINCIPAL_INVESTIGATOR
References: