AtelectasisNCT05821998
Effect of Thoracic Block Technique on Arterial Blood Gases in Children With Atelectasis 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 arterial blood gases, vital signs and lung compliance in children with atelectasis on mechanical ventilation? Null hyposis there is no effect of thoracic block technique on arterial blood gases, vital signs and lung compliance in children with… Read more about this study
- Who is it for?
- Ages 4 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
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 31 May 2023
- 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 4 months to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age range from 4 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.
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.
- rib fracture.
- pneumothorax -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Thoracic Block Technique on Arterial Blood Gases, Vital Signs and Lung Compliance in Children With Atelectasis on Mechanical Ventilation
Statement of the problem:
- Does the thoracic block technique has effect on arterial blood gases, vital signs and lung compliance in children with atelectasis on mechanical ventilation? Null hyposis there is no effect of thoracic block technique on arterial blood gases, vital signs and lung compliance in children with atelectasis on mechanical ventilation.
Read the detailed description
Subjects:
The study targets the children from both sexes.diagnosed with atelectasis in intensive care unit. Sample size estimation will be carried out to determine the recruited number of children, selected randomly from Cairo University pediatric specialized hospital, Cairo to participate in the study,
Study design:
Randomized controlled clinical trial. Children will receive intervention type randomly, 22 child received percussion, vibration, modified postural drainage and the other 22 child will receive percussion, vibration, modified postural drainage and thoracic block technique.
Children will be assessed by measuring heart rate, respiratory rate,which reflect the physiological status, arterial blood gases which include partial pressure of oxygen (PaO2), partial pressure of carbon dioxide (PaCO2) and oxygen saturation (SaO2) and dynamic lung compliance which reflect clinical improvement of chest condition 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 modified 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 and modified postural drainage on 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 modified 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 oxygenation status
Assessment of change of partial pressure of arterial oxygen which is one value in arterial blood gases test results which calculated by arterial blood gases analyzier and comparing results before and after intervention
Measured: 10 days for each participant
Assessment of ventilation status
Assessment of change of partial pressure of carbon dioxide which is one value of arterial blood gases test results and calculated by arterial blood gases analyzier before and after intervention
Measured: 10 days for each participant
Assessment of dynamic lung compliance
Assessment of change in lung compliance value during air flow which calculated automatically by mechanical ventilator, we record it 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 posted20 Apr 2023
- Study start1 Dec 2022
- Primary completion25 May 2023
- Study completion31 May 2023
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
- 44 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
- NCT05821998
- Sponsor's protocol ID
- P. T. REC/012/004401
- Status last verified
- Jul 2023
- First submitted
- 25 Mar 2023
- Last updated
- 1 Aug 2023
- 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 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thoracic Block Technique on Arterial Blood Gases, Vital Signs and Lung Compliance in Children With Atelectasis on Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT05821998
- Acronym / sponsor ID
- P. T. REC/012/004401
- Conditions
- Atelectasis, Intensive Care Unit, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 20 Apr 2023 (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 arterial blood gases, vital signs and lung compliance in children with atelectasis on mechanical ventilation? Null hyposis there is no effect of thoracic block technique on arterial blood gases, vital signs and lung compliance in children with atelectasis on mechanical ventilation.
Detailed description
Subjects:
The study targets the children from both sexes.diagnosed with atelectasis in intensive care unit. Sample size estimation will be carried out to determine the recruited number of children, selected randomly from Cairo University pediatric specialized hospital, Cairo to participate in the study,
Study design:
Randomized controlled clinical trial. Children will receive intervention type randomly, 22 child received percussion, vibration, modified postural drainage and the other 22 child will receive percussion, vibration, modified postural drainage and thoracic block technique.
Children will be assessed by measuring heart rate, respiratory rate,which reflect the physiological status, arterial blood gases which include partial pressure of oxygen (PaO2), partial pressure of carbon dioxide (PaCO2) and oxygen saturation (SaO2) and dynamic lung compliance which reflect clinical improvement of chest condition 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 and modified postural drainage on 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 modified postural drainage for 30 minutes every day for ten days |
Who may qualify
- Ages
- 4 months to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- age range from 4 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 (5 listed)
- medically unstable ( examples: tachycardia and tachypnea)
- uncontrolled convulsion.
- 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 modified postural drainage | Other | Designed chest physical therapy program |
Primary outcome
Assessment of oxygenation status
Time frame: 10 days for each participant
Assessment of change of partial pressure of arterial oxygen which is one value in arterial blood gases test results which calculated by arterial blood gases analyzier and comparing results before and after intervention
Assessment of ventilation status
Time frame: 10 days for each participant
Assessment of change of partial pressure of carbon dioxide which is one value of arterial blood gases test results and calculated by arterial blood gases analyzier before and after intervention
Assessment of dynamic lung compliance
Time frame: 10 days for each participant
Assessment of change in lung compliance value during air flow which calculated automatically by mechanical ventilator, we record it 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 1 Aug 2023.
Related trials for Atelectasis
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Active, not recruiting
Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients
Recruitment, Bariatric Surgery Candidate
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
Recruiting
Bronchoscopic Airway Clearance for Improving Lung Aeration in Mechanically Ventilated Patients With Atelectasis
Atelectasis, Mechanical Ventilation
Not yet recruitingObservational study
Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress
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 5 inclusion and 5 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 1 Aug 2023. 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 oxygenation status (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 1 Aug 2023.