Lung Injury, AcuteNCT05647967
Features of Regional Perfusion of Lung Consolidation
An observational study of Lung Injury, Acute and Ultrasound Therapy; Complications, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The aim of this study is to evaluate the potential usefulness of lung ultrasound to assess the size and perfusion of consolidation and explore their relationships with clinical outcome. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Injury, Acute, Ultrasound Therapy; Complications
- What is being tested?
- Ultrasound
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Jan 2024
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of adult(>18yr) patients admitted to the ICU. Patients presented with acute respiratory failure and pulmonary consolidation by chest imaging (lung ultrasound, X ray or CT scan) were eligible for inclusion. Acute respiratory failure was defined by at least one of the following criteria: PaO2/FiO2<300mmHg, breathing frequencies>30 breath/min, and could involve many potential causes of hypoxemia (e.g., sepsis, atelectasis, pneumonia, acute exacerbation of chronic lung disease).
Who may be able to join
- Admission to ICU( 18yr<age<90yr);
- Patients presented with acute respiratory failure;
- Pulmonary consolidation by chest imaging (lung ultrasound, X ray or CT scan).
Who cannot join
- Hemodynamic instability (i.e., severe hypotension with systolic arterial pressure<60mmHg despite fluid expansion and vasoactive support; systolic arterial pressure>180mmHg; uncontrolled cardiac arrhythmias);
- Severe thoracic trauma;
- Coronavirus disease 2019;
- Pulmonary artery hypertension and pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking union medical college hospital
Beijing, Beijing Municipality, 100010
Na Wang, MD, 17810258960, wangna_pumch2017@163.com
About this study
Official title: Evaluation of Regional Perfusion of Lung Consolidation Upon Lung Ultrasonography
The aim of this study is to evaluate the potential usefulness of lung ultrasound to assess the size and perfusion of consolidation and explore their relationships with clinical outcome.
Read the detailed description
Lung consolidation is one of the most causes of hypoxia in intensive care unit(ICU) settings. A quantitative measurement of consolidation would be extremely benefit for the clinical management in hypoxemia, both as an index of severity and to predict outcomes.In order to quantify the lung consolidation and its effect on clinical outcomes, a simple and quantitative scoring system of the size and perfusion of lung consolidation was proposed by lung ultrasound. Subjects with respiratory failure and lung consolidation proved by chest imaging underwent lung ultrasound examination. The size of consolidation and the richness of blood flow was computed upon lung ultrasound. The sensitivity, specificity and accuracy of the scoring system were calculated and compared to evaluate the diagnostic efficacy.
- Being tested
- Ultrasound
- Keywords
- lung consolidation, respiratory failure, perfusion
- Medical subject headings
- Acute Lung Injury, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Each patient underwent ultrasound after admission of ICU.
| Study group | Role | What they receive |
|---|---|---|
| the consolidation perfusion/the consolidation size | Patients with respiratory failure and lung consolidation proved by chest imaging underwent lung ultrasound to evaluate the regional perfusion and the size of consolidation. Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
consolidation area index
The volume of consolidation was measured by consolidation area index (CAI) which is calculated from two-dimensional measures, namely the product of the core distance (from the bottom to the top of the screen) and the longitudinal distance (from the left to the right of the screen).
Measured: through study completion, an average of 2 year
blood flow score
A semi-quantified scoring system based on the richness of flow signals was established. It identifies four progressive steps of blood signals, each corresponding to a score: no pulsatile blood flow-score 0; sparse dot-like blood flow-score 1; pronounced curvilinear vascularity-score 2; tree-like vascularity-score 3.
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Injury, AcuteStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huaiwu He, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647967
- Sponsor's protocol ID
- I-22PJ140
- Status last verified
- Nov 2022
- First submitted
- 29 Nov 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang N, Chi Y, Wang Q, Long Y, Liu D, Zhao Z, He H. Relationship between lung consolidation size measured by ultrasound and outcome in ICU patients with respiratory failure. BMC Pulm Med. 2025 Feb 26;25(1):91. doi: 10.1186/s12890-025-03564-6.
PubMed 40011857
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Regional Perfusion of Lung Consolidation Upon Lung Ultrasonography
- ClinicalTrials.gov ID
- NCT05647967
- Acronym / sponsor ID
- I-22PJ140
- Keywords
- lung consolidation, respiratory failure, perfusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 13 Dec 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.
The aim of this study is to evaluate the potential usefulness of lung ultrasound to assess the size and perfusion of consolidation and explore their relationships with clinical outcome.
Detailed description
Lung consolidation is one of the most causes of hypoxia in intensive care unit(ICU) settings. A quantitative measurement of consolidation would be extremely benefit for the clinical management in hypoxemia, both as an index of severity and to predict outcomes.In order to quantify the lung consolidation and its effect on clinical outcomes, a simple and quantitative scoring system of the size and perfusion of lung consolidation was proposed by lung ultrasound. Subjects with respiratory failure and lung consolidation proved by chest imaging underwent lung ultrasound examination. The size of consolidation and the richness of blood flow was computed upon lung ultrasound. The sensitivity, specificity and accuracy of the scoring system were calculated and compared to evaluate the diagnostic efficacy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the consolidation perfusion/the consolidation size | – | Diagnostic Test: UltrasoundPatients with respiratory failure and lung consolidation proved by chest imaging underwent lung ultrasound to evaluate the regional perfusion and the size of consolidation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adult(>18yr) patients admitted to the ICU. Patients presented with acute respiratory failure and pulmonary consolidation by chest imaging (lung ultrasound, X ray or CT scan) were eligible for inclusion. Acute respiratory failure was defined by at least one of the following criteria: PaO2/FiO2<300mmHg, breathing frequencies>30 breath/min, and could involve many potential causes of hypoxemia (e.g., sepsis, atelectasis, pneumonia, acute exacerbation of chronic lung disease).
Key inclusion criteria (3 listed)
- Admission to ICU( 18yr<age<90yr);
- Patients presented with acute respiratory failure;
- Pulmonary consolidation by chest imaging (lung ultrasound, X ray or CT scan).
Key exclusion criteria (4 listed)
- Hemodynamic instability (i.e., severe hypotension with systolic arterial pressure<60mmHg despite fluid expansion and vasoactive support; systolic arterial pressure>180mmHg; uncontrolled cardiac arrhythmias);
- Severe thoracic trauma;
- Coronavirus disease 2019;
- Pulmonary artery hypertension and pregnancy.
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 |
|---|---|---|
| UltrasoundEach patient underwent ultrasound after admission of ICU. | Diagnostic test | the consolidation perfusion/the consolidation size |
Primary outcome
consolidation area index
Time frame: through study completion, an average of 2 year
The volume of consolidation was measured by consolidation area index (CAI) which is calculated from two-dimensional measures, namely the product of the core distance (from the bottom to the top of the screen) and the longitudinal distance (from the left to the right of the screen).
blood flow score
Time frame: through study completion, an average of 2 year
A semi-quantified scoring system based on the richness of flow signals was established. It identifies four progressive steps of blood signals, each corresponding to a score: no pulsatile blood flow-score 0; sparse dot-like blood flow-score 1; pronounced curvilinear vascularity-score 2; tree-like vascularity-score 3.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Derived from this study: PubMed 40011857Wang N, Chi Y, Wang Q, Long Y, Liu D, Zhao Z, He H. Relationship between lung consolidation size measured by ultrasound and outcome in ICU patients with respiratory failure. BMC Pulm Med. 2025 Feb 26;25(1):91. doi: 10.1186/s12890-025-03564-6.
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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.
Huaiwu He, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Injury, Acute and Ultrasound Therapy; Complications, run by Peking Union Medical College Hospital at 1 site in China.
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 3 inclusion and 4 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 13 Dec 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Na Wang, MD (17810258960, wangna_pumch2017@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
consolidation area index (time frame: through study completion, an average of 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05647967, which also lists 1 linked publication.
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 13 Dec 2022.