Pulmonary ComplicationNCT06498895
Lung Ultrasound Score as Post Operative Predictive Value of Pulmonary Complications in Living Liver Transplant Recipient
An observational study of Pulmonary Complication and Post Operative Complication, run by Ain Shams University.
Trial summary
The aim of this study is to determine if lung ultrasound score has a strong predictive value for post operative pulmonary complications in living liver transplant recipient Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Pulmonary Complication, Post Operative Complication
- What is being tested?
- lung ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 25 Aug 2025to 10 Sep 2025
- Phase
- Observational
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: • Study Population: living liver transplant recipient patients post operative in intensive care unit ( 25 patients ), all patients included in this study will be subjected to lung ultrasound score at the pre mentioned times (0,12,24) by most senior expert staff then follow up of patients in intensive care unit will reveal that patients will be divided into two groups according to occurance of lung complications to post operative pulmonary complications positive ( group that developed pulmonary complications ) and post operative pulmonary complications negative (group that didn't develop pulmonary complications ) then sensitivity, specificity and predictive value of lung ultrasound score will be determined
Who may be able to join
- living liver transplant recipient patients post operative in intensive care unit in first day
- Age ( Adults 21-60 )
- Sex ( both genders will be included )
- ASA 4 liver failure patients .
Who cannot join
- Presence of preoperative chronic lung diseases
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to determine if lung ultrasound score has a strong predictive value for post operative pulmonary complications in living liver transplant recipient
Read the detailed description
Back ground :Traditional diagnostic tools such as auscultation or chest x-ray have inferior diagnostic accuracy compared to the gold standard (chest computed tomography), Lung ultrasound is becoming popular in intensive and perioperative care and there is a growing interest to evaluate its role in the detection of postoperative pulmonary pathologies.
METHODOLOGY Type of Study: observational prospective study
- Study Setting: After obtaining approval from the Research Ethical Committee of Ain Shams University, this study will be conducted in specialized Ain Shams University Hospitals.
- Study Population : living liver transplant recipient patients post operative in intensive care unit ( 25 patients ), all patients included in this study will be subjected to lung ultrasound score at the pre mentioned times (0,12,24) by most senior expert staff then follow up of patients in Intensive care unit,will reveal that patients will be divided into two groups according to occurance of lung complications to Pulmonary complications positive ( group that developed pulmonary complications ) and pulmonary complications negative (group that didn't develop pulmonary complications ) then sensitivity, specificity and predictive value of lung ultrasound score will be determined .
- Being tested
- lung ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung ultrasoundRadiation
Lung ultrasound score will be done within one hour of admission,12 hours post admission then 24 hours in intensive care unit,follow up of patients will continue for 72 hours .
a complete lung ultrasound evaluation will be performed using low frequency curved probe (2MHz-5MHz) according to the lung ultrasound score . The external lung fields will be examined by longitudinal and transverse plane scans, dividing the surface of the thorax into 12 zones: 6 on the right (anterior: upper R1 and lower R2; lateral; upper R3 and lower R4; posterior: upper R5 and lower R6) and 6 on the left side (front: upper L1 and lower L2; lateral: upper L3 and lower L4; rear: upper L5 and lower L6). LUS assigns 0 points to A lines or < 2 separate B lines plus regular sliding; 1 point with lines B ≥ 3 or spaced focal points plus regular sliding; 2 points with coalescing B lines, and 3 points to pulmonary consolidations for each zone with a score ranging from 0 (normal lungs) to 36 (worst case scenario)
| Study group | Role | What they receive |
|---|---|---|
| post operative living liver transplant recipient | lung ultrasound score will be done in first 24 hours in intensive care unit for living liver transplant recipient patient Receives: Radiation: lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung ultrasound score
Measured: first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start25 Aug 2025 (estimated)
- Primary completion10 Sep 2025 (estimated)
- Study completion10 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary ComplicationStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498895
- Sponsor's protocol ID
- MD102/2024
- Status last verified
- Sep 2024
- First submitted
- 6 Jul 2024
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound Score as Post Operative Predictive Value of Pulmonary Complications in Living Liver Transplant Recipient
- ClinicalTrials.gov ID
- NCT06498895
- Acronym / sponsor ID
- MD102/2024
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Aug 2025 (estimated)
- Primary completion
- 10 Sep 2025 (estimated)
- Study completion
- 10 Sep 2025 (estimated)
- First posted
- 12 Jul 2024 (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.
The aim of this study is to determine if lung ultrasound score has a strong predictive value for post operative pulmonary complications in living liver transplant recipient
Detailed description
Back ground :Traditional diagnostic tools such as auscultation or chest x-ray have inferior diagnostic accuracy compared to the gold standard (chest computed tomography), Lung ultrasound is becoming popular in intensive and perioperative care and there is a growing interest to evaluate its role in the detection of postoperative pulmonary pathologies.
METHODOLOGY Type of Study: observational prospective study
- Study Setting: After obtaining approval from the Research Ethical Committee of Ain Shams University, this study will be conducted in specialized Ain Shams University Hospitals.
- Study Population : living liver transplant recipient patients post operative in intensive care unit ( 25 patients ), all patients included in this study will be subjected to lung ultrasound score at the pre mentioned times (0,12,24) by most senior expert staff then follow up of patients in Intensive care unit,will reveal that patients will be divided into two groups according to occurance of lung complications to Pulmonary complications positive ( group that developed pulmonary complications ) and pulmonary complications negative (group that didn't develop pulmonary complications ) then sensitivity, specificity and predictive value of lung ultrasound score will be determined .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| post operative living liver transplant recipient | – | Radiation: lung ultrasoundlung ultrasound score will be done in first 24 hours in intensive care unit for living liver transplant recipient patient |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- • Study Population: living liver transplant recipient patients post operative in intensive care unit ( 25 patients ), all patients included in this study will be subjected to lung ultrasound score at the pre mentioned times (0,12,24) by most senior expert staff then follow up of patients in intensive care unit will reveal that patients will be divided into two groups according to occurance of lung complications to post operative pulmonary complications positive ( group that developed pulmonary complications ) and post operative pulmonary complications negative (group that didn't develop pulmonary complications ) then sensitivity, specificity and predictive value of lung ultrasound score will be determined
Key inclusion criteria (4 listed)
- living liver transplant recipient patients post operative in intensive care unit in first day
- Age ( Adults 21-60 )
- Sex ( both genders will be included )
- ASA 4 liver failure patients .
Key exclusion criteria (1 listed)
- Presence of preoperative chronic lung diseases
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 |
|---|---|---|
| lung ultrasoundLung ultrasound score will be done within one hour of admission,12 hours post admission then 24 hours in intensive care unit,follow up of patients will continue for 72 hours . a complete lung ultrasound evaluation will be performed using low frequency curved probe (2MHz-5MHz) according to the lung ultrasound score . The external lung fields will be examined by longitudinal and transverse plane scans, dividing the surface of the thorax into 12 zones: 6 on the right (anterior: upper R1 and lower R2; lateral; upper R3 and lower R4; posterior: upper R5 and lower R6) and 6 on the left side (front: upper L1 and lower L2; lateral: upper L3 and lower L4; rear: upper L5 and lower L6). LUS assigns 0 points to A lines or < 2 separate B lines plus regular sliding; 1 point with lines B ≥ 3 or spaced focal points plus regular sliding; 2 points with coalescing B lines, and 3 points to pulmonary consolidations for each zone with a score ranging from 0 (normal lungs) to 36 (worst case scenario) | Radiation | post operative living liver transplant recipient |
Primary outcome
lung ultrasound score
Time frame: first 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Complication and Post Operative Complication, run by Ain Shams University.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina refaat (+01202243566, marina2931994@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lung ultrasound score (time frame: first 24 hours). 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 6 Aug 2025.