AtelectasisNCT05480202
Effect of Thoracic Block Technique on Atelectasis in Children on Mechanical Ventilation
A study testing Thoracic block technique and Designed chest physical therapy program in people with Atelectasis and Intensive Care Unit, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 4 years
- Conditions the study is for
- Atelectasis, Intensive Care Unit, Children
- What is being tested?
- Thoracic block technique and Designed chest physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Dec 2021to 20 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- Exclusion criteria:
- The children were excluded from the study if they had one of the following:
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- 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.
- 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
- Conditions
- Atelectasis, Intensive Care Unit, Children
- Being tested
- Thoracic block technique, Designed chest physical therapy program
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic block techniqueOther
Also called Technique of insufflation to reverse atelectasis
Manual compression of the healthy lung during expiration associated with the use of invasive or non invasive mechanical ventilation
Designed chest physical therapy programOther
Percussion, vibration and postural drainage
| Study group | Role | What they receive |
|---|---|---|
| Thoracic block technique and designed chest physical therapy program | Experimental | 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 Receives: Other: Thoracic block technique |
| Designed chest physical therapy program | Active comparator | Percussion, vibration and postural drainage for 30 minutes every day for ten days Receives: Other: Designed chest physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 10 days for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start6 Dec 2021
- Primary completion10 Jul 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Abdallah Amin, Cairo University
- Investigators
- Alaa Abdallah, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480202
- Sponsor's protocol ID
- P. T. REC/012/003483
- Status last verified
- Jul 2022
- First submitted
- 26 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thoracic Block Technique on Atelectasis in Children on Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT05480202
- Acronym / sponsor ID
- P. T. REC/012/003483
- Conditions
- Atelectasis, Intensive Care Unit, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 10 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic block technique and designed chest physical therapy program | Experimental | Other: Thoracic block techniqueManual 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 |
| Designed chest physical therapy program | Active comparator | Other: Designed chest physical therapy programPercussion, vibration and postural drainage for 30 minutes every day for ten days |
Who may qualify
- Ages
- 6 months to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- medically unstable ( examples: tachycardia and tachypnea).
- uncontrolled convulsion.
- irritable or moderate to sever pain
- rib fracture
- pneumothorax
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic block techniqueAlso: Technique of insufflation to reverse atelectasisManual compression of the healthy lung during expiration associated with the use of invasive or non invasive mechanical ventilation | Other | Thoracic block technique and designed chest physical therapy program |
| Designed chest physical therapy programPercussion, vibration and postural drainage | Other | Designed chest physical therapy program |
Primary outcome
Assessment of heart rate and respiratory rate
Time frame: 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
Time frame: 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
Time frame: 10 days for each participant
Assessment of change in arterial blood gases test will be carried out by comparing results before and after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaa Abdallah principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic block technique and Designed chest physical therapy program in people with Atelectasis and Intensive Care Unit, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of heart rate and respiratory rate (time frame: 10 days for each participant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.