RetrospectiveNCT06521515
Lung Ultrasound Morphology Patterns Predict Weaning Outcomes
An observational study of Retrospective, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This prospective observational study aims to investigate the impact of lung ultrasound morphology patterns on treatment response and weaning outcomes in high-risk mechanically ventilated patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Retrospective
- What is being tested?
- Lung Ultrasound Morphology Patterns
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 30 Dec 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be retrospective. Based on lung ultrasound morphology patterns, patients will be stratified into localized tissue-like patterns (TLP) and diffuse B-lines (DBP) groups. The study will enroll a diverse population to ensure generalizability and comprehensively analyze the relationship between lung ultrasound morphology patterns, treatment response, and weaning outcomes.
Inclusion criteria:(1) age ≥18 years, (2) on mechanical ventilation >24 hours before the first spontaneous breathing trial, (3) high risk for reintubation due to age (>65 years) or chronic heart or lung disease, and (4) complete ultrasound data and initial LUS >13.
Exclusion criteria:(1) age under 18 years, pregnancy, mechanical ventilation duration less than 24 hours, or diaphragmatic dysfunction; (2) low risk of extubation failure; (3) peripheral neuromuscular disorders; or (4) do-not-reintubate order at the first spontaneous breathing trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hongyu He
Shanghai, Shanghai Municipality, 200032
Hongyu He, he.hongyu@zs-hospital.sh.cn
About this study
Official title: The Impact of Lung Ultrasound Morphology Patterns on Treatment Response and Weaning Outcomes in High-Risk Mechanically Ventilated Patients
This prospective observational study aims to investigate the impact of lung ultrasound morphology patterns on treatment response and weaning outcomes in high-risk mechanically ventilated patients. The study will be conducted in the intensive care unit (ICU) and will include patients who have been on mechanical ventilation for over 24 hours, are at high risk for reintubation due to age (>65 years) or underlying conditions (chronic heart or lung disease), and have a Lung Ultrasound Score (LUS) >13.
Patients will be stratified into two groups based on their lung ultrasound patterns: localized tissue-like patterns (TLP) and diffuse B-lines (DBP). Daily lung ultrasound examinations will be performed, and patients will receive targeted clinical interventions based on their ultrasound findings, such as lung recruitment maneuvers, positive end-expiratory pressure (PEEP) ventilation, prone positioning, pleural effusion drainage, antibiotics for pneumonia, and strategies for achieving negative fluid balance.
Read more
The primary outcome will be the change in Lung Recruitment Score (LRS) between the TLP and DBP groups, which assesses lung recruitment efficiency. Secondary outcomes will include the rate of weaning failure, duration of mechanical ventilation, ICU mortality, total ICU stay duration, and PaO2/FiO2 ratio before and after the spontaneous breathing trial (SBT).
This study aims to provide insights into the utility of lung ultrasound morphology patterns in guiding clinical interventions and predicting weaning outcomes in high-risk mechanically ventilated patients, potentially leading to improved patient care and outcomes in the ICU setting.
Read the detailed description
This prospective observational study, titled "Lung Ultrasound Morphology Patterns Predict Weaning Outcomes (LUMP-WO)," aims to investigate the impact of lung ultrasound morphology patterns on treatment response and weaning outcomes in high-risk mechanically ventilated patients. The study will be conducted in the intensive care unit (ICU) of a tertiary care hospital.
Inclusion criteria for the study are: (1) mechanical ventilation for over 24 hours before the first spontaneous breathing trial, (2) high risk for reintubation due to age (>65 years) or underlying conditions (chronic heart disease or chronic lung disease), and (3) complete ultrasound data and initial LUS score >13. Exclusion criteria include: (1) age under 18 years, pregnancy, mechanical ventilation duration less than 24 hours, or diaphragmatic dysfunction; (2) low risk of extubation failure; (3) peripheral neuromuscular disorders; or (4) do-not-reintubate order at the first spontaneous breathing trial.
Patients will undergo daily lung ultrasound examinations performed by blinded investigators. Each lung will be scanned in six regions, and ultrasound findings will be categorized into four aeration patterns: normal (N-score 0), moderate (B1-lines score 1), severe (B2-lines score 2), and consolidation (C-score 3). The global LUS score will range from 0 to 36. Patients will be grouped into TLP if they exhibit a tissue-like pattern in any region or DBP if they display diffuse B-lines and shred signs in most regions.
Patients will receive standard medical care and targeted interventions based on their lung ultrasound findings. Lung recruitment maneuvers, PEEP ventilation, prone positioning, pleural effusion drainage, antibiotics for pneumonia, and strategies for achieving negative fluid balance will be utilized as appropriate. Weaning criteria will be assessed daily, and the Spontaneous Breathing Test (SBT) will be conducted using a T-tube or mechanical ventilation with low PEEP and pressure support.
The primary outcome will be the change in Lung Recruitment Score (LRS) between the TLP and DBP groups. Secondary outcomes will include the rate of weaning failure, duration of mechanical ventilation, ICU mortality, total ICU stay duration, and PaO2/FiO2 ratio before and after the SBT.
Data will be analyzed using appropriate statistical tests, and univariate and multivariate regression analyses will be utilized to identify risk factors associated with weaning outcomes.
This study aims to provide valuable insights into the utility of lung ultrasound morphology patterns in guiding clinical interventions and predicting weaning outcomes in high-risk mechanically ventilated patients. The findings may contribute to the development of personalized management strategies and improved patient outcomes in the ICU setting. The study's results may also help in the early identification of patients at risk of weaning failure, allowing for timely interventions and resource allocation.
- Conditions
- Retrospective
- Being tested
- Lung Ultrasound Morphology Patterns
- Keywords
- weaning, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Ultrasound Morphology PatternsDiagnostic test
Two blinded investigators conducted daily lung ultrasound examinations. Each lung was scanned in six regions, categorizing ultrasound findings into four aeration patterns: normal (N-score 0), moderate (B1-lines score 1), severe (B2-lines score 2), and consolidation (C-score 3). The global LUS score ranged from 0 to 36. Patients were grouped into TLP if they exhibited a tissue-like pattern in any region or DBP if they displayed diffuse B-lines and shred signs in most regions. Localized TLPs indicated concentrated areas of non-aeration.
| Study group | Role | What they receive |
|---|---|---|
| TLP group | Patients were grouped into TLP if they exhibited a tissue-like pattern in any region Receives: Diagnostic Test: Lung Ultrasound Morphology Patterns | |
| DBP group | Patients were grouped into DBP if they displayed diffuse B-lines and shred signs in most regions. Receives: Diagnostic Test: Lung Ultrasound Morphology Patterns |
What is being measured
The primary outcome is the main question the study is designed to answer.
LRS
The primary endpoint of the study was the change in Lung Recruitment Score (LRS) between the TLP and DBP groups. LRS assesses lung recruitment efficiency, assigning positive scores for reaeration and negative scores for loss of aeration (
Measured: through study completion，up to 28 days
Secondary outcomes (5)
weaning failure rates
defined as inability to successfully complete a spontaneous breathing trial, need for mechanical ventilation reintroduction within 48 hours post-weaning, or mortality related to weaning.
Measured: through study completion,up to 28 days
duration of mechanical ventilation
the total number of days or hours a patient receives invasive mechanical ventilation support
Measured: through study completion,up to 28 days
ICU mortality
the proportion of patients who die during their stay in the intensive care unit (ICU).
Measured: through study completion,up to 28 days
total ICU stay duration
the number of days a patient remains in the ICU from admission to discharge, transfer to another unit, or death.
Measured: through study completion,up to 28 days
PaO2/FiO2 ratio before and after the spontaneous breathing trial (SBT)
The PaO2/FiO2 ratio will be calculated by dividing the partial pressure of arterial oxygen (PaO2) by the fraction of inspired oxygen (FiO2). Measurements will be taken at two time points: (1) immediately before the start of the SBT and (2) at the end of the SBT or at the time of SBT failure.
Measured: through study completion,up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Sep 2021
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for RetrospectiveStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Zhong, Ph.D, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521515
- Sponsor's protocol ID
- LUMP-WO
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data (IPD) sharing plan for this study will involve making specific datasets available to other researchers upon request and after the publication of the primary study results. The IPD to be shared will include de-identified data on patient demographics, clinical characteristics, lung ultrasound findings, treatment interventions, and outcomes, such as the duration of mechanical ventilation, ICU mortality, total ICU stay duration, and PaO2/FiO2 ratio before and after the spontaneous breathing trial (SBT).
Publications
Bello G, Blanco P. Lung Ultrasonography for Assessing Lung Aeration in Acute Respiratory Distress Syndrome: A Narrative Review. J Ultrasound Med. 2019 Jan;38(1):27-37. doi: 10.1002/jum.14671. Epub 2018 May 6.
PubMed 29732586Mojoli F, Bouhemad B, Mongodi S, Lichtenstein D. Lung Ultrasound for Critically Ill Patients. Am J Respir Crit Care Med. 2019 Mar 15;199(6):701-714. doi: 10.1164/rccm.201802-0236CI.
PubMed 30372119Mayo P, Volpicelli G, Lerolle N, Schreiber A, Doelken P, Vieillard-Baron A. Ultrasonography evaluation during the weaning process: the heart, the diaphragm, the pleura and the lung. Intensive Care Med. 2016 Jul;42(7):1107-17. doi: 10.1007/s00134-016-4245-3. Epub 2016 Mar 7.
PubMed 26951426
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Lung Ultrasound Morphology Patterns on Treatment Response and Weaning Outcomes in High-Risk Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT06521515
- Acronym / sponsor ID
- LUMP-WO
- Conditions
- Retrospective
- Keywords
- weaning, ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 26 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.
This prospective observational study aims to investigate the impact of lung ultrasound morphology patterns on treatment response and weaning outcomes in high-risk mechanically ventilated patients. The study will be conducted in the intensive care unit (ICU) and will include patients who have been on mechanical ventilation for over 24 hours, are at high risk for reintubation due to age (>65 years) or underlying conditions (chronic heart or lung disease), and have a Lung Ultrasound Score (LUS) >13.
Patients will be stratified into two groups based on their lung ultrasound patterns: localized tissue-like patterns (TLP) and diffuse B-lines (DBP). Daily lung ultrasound examinations will be performed, and patients will receive targeted clinical interventions based on their ultrasound findings, such as lung recruitment maneuvers, positive end-expiratory pressure (PEEP) ventilation, prone positioning, pleural effusion drainage, antibiotics for pneumonia, and strategies for achieving negative fluid balance.
The primary outcome will be the change in Lung Recruitment Score (LRS) between the TLP and DBP groups, which assesses lung recruitment efficiency. Secondary outcomes will include the rate of weaning failure, duration of mechanical ventilation, ICU mortality, total ICU stay duration, and PaO2/FiO2 ratio before and after the spontaneous breathing trial (SBT).
This study aims to provide insights into the utility of lung ultrasound morphology patterns in guiding clinical interventions and predicting weaning outcomes in high-risk mechanically ventilated patients, potentially leading to improved patient care and outcomes in the ICU setting.
Detailed description
This prospective observational study, titled "Lung Ultrasound Morphology Patterns Predict Weaning Outcomes (LUMP-WO)," aims to investigate the impact of lung ultrasound morphology patterns on treatment response and weaning outcomes in high-risk mechanically ventilated patients. The study will be conducted in the intensive care unit (ICU) of a tertiary care hospital.
Inclusion criteria for the study are: (1) mechanical ventilation for over 24 hours before the first spontaneous breathing trial, (2) high risk for reintubation due to age (>65 years) or underlying conditions (chronic heart disease or chronic lung disease), and (3) complete ultrasound data and initial LUS score >13. Exclusion criteria include: (1) age under 18 years, pregnancy, mechanical ventilation duration less than 24 hours, or diaphragmatic dysfunction; (2) low risk of extubation failure; (3) peripheral neuromuscular disorders; or (4) do-not-reintubate order at the first spontaneous breathing trial.
Patients will undergo daily lung ultrasound examinations performed by blinded investigators. Each lung will be scanned in six regions, and ultrasound findings will be categorized into four aeration patterns: normal (N-score 0), moderate (B1-lines score 1), severe (B2-lines score 2), and consolidation (C-score 3). The global LUS score will range from 0 to 36. Patients will be grouped into TLP if they exhibit a tissue-like pattern in any region or DBP if they display diffuse B-lines and shred signs in most regions.
Patients will receive standard medical care and targeted interventions based on their lung ultrasound findings. Lung recruitment maneuvers, PEEP ventilation, prone positioning, pleural effusion drainage, antibiotics for pneumonia, and strategies for achieving negative fluid balance will be utilized as appropriate. Weaning criteria will be assessed daily, and the Spontaneous Breathing Test (SBT) will be conducted using a T-tube or mechanical ventilation with low PEEP and pressure support.
The primary outcome will be the change in Lung Recruitment Score (LRS) between the TLP and DBP groups. Secondary outcomes will include the rate of weaning failure, duration of mechanical ventilation, ICU mortality, total ICU stay duration, and PaO2/FiO2 ratio before and after the SBT.
Data will be analyzed using appropriate statistical tests, and univariate and multivariate regression analyses will be utilized to identify risk factors associated with weaning outcomes.
This study aims to provide valuable insights into the utility of lung ultrasound morphology patterns in guiding clinical interventions and predicting weaning outcomes in high-risk mechanically ventilated patients. The findings may contribute to the development of personalized management strategies and improved patient outcomes in the ICU setting. The study's results may also help in the early identification of patients at risk of weaning failure, allowing for timely interventions and resource allocation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TLP group | – | Diagnostic Test: Lung Ultrasound Morphology PatternsPatients were grouped into TLP if they exhibited a tissue-like pattern in any region |
| DBP group | – | Diagnostic Test: Lung Ultrasound Morphology PatternsPatients were grouped into DBP if they displayed diffuse B-lines and shred signs in most regions. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be retrospective. Based on lung ultrasound morphology patterns, patients will be stratified into localized tissue-like patterns (TLP) and diffuse B-lines (DBP) groups. The study will enroll a diverse population to ensure generalizability and comprehensively analyze the relationship between lung ultrasound morphology patterns, treatment response, and weaning outcomes.
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 Ultrasound Morphology PatternsTwo blinded investigators conducted daily lung ultrasound examinations. Each lung was scanned in six regions, categorizing ultrasound findings into four aeration patterns: normal (N-score 0), moderate (B1-lines score 1), severe (B2-lines score 2), and consolidation (C-score 3). The global LUS score ranged from 0 to 36. Patients were grouped into TLP if they exhibited a tissue-like pattern in any region or DBP if they displayed diffuse B-lines and shred signs in most regions. Localized TLPs indicated concentrated areas of non-aeration. | Diagnostic test | DBP group, TLP group |
Primary outcome
LRS
Time frame: through study completion，up to 28 days
The primary endpoint of the study was the change in Lung Recruitment Score (LRS) between the TLP and DBP groups. LRS assesses lung recruitment efficiency, assigning positive scores for reaeration and negative scores for loss of aeration (
5 secondary outcomes
weaning failure rates
Time frame: through study completion,up to 28 days
duration of mechanical ventilation
Time frame: through study completion,up to 28 days
ICU mortality
Time frame: through study completion,up to 28 days
total ICU stay duration
Time frame: through study completion,up to 28 days
PaO2/FiO2 ratio before and after the spontaneous breathing trial (SBT)
Time frame: through study completion,up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Results publication: PubMed 29732586Bello G, Blanco P. Lung Ultrasonography for Assessing Lung Aeration in Acute Respiratory Distress Syndrome: A Narrative Review. J Ultrasound Med. 2019 Jan;38(1):27-37. doi: 10.1002/jum.14671. Epub 2018 May 6.
- Results publication: PubMed 30372119Mojoli F, Bouhemad B, Mongodi S, Lichtenstein D. Lung Ultrasound for Critically Ill Patients. Am J Respir Crit Care Med. 2019 Mar 15;199(6):701-714. doi: 10.1164/rccm.201802-0236CI.
- Results publication: PubMed 26951426Mayo P, Volpicelli G, Lerolle N, Schreiber A, Doelken P, Vieillard-Baron A. Ultrasonography evaluation during the weaning process: the heart, the diaphragm, the pleura and the lung. Intensive Care Med. 2016 Jul;42(7):1107-17. doi: 10.1007/s00134-016-4245-3. Epub 2016 Mar 7.
- Individual participant dataSharing planned: Yes. The individual participant data (IPD) sharing plan for this study will involve making specific datasets available to other researchers upon request and after the publication of the primary study results. The IPD to be shared will include de-identified data on patient demographics, clinical characteristics, lung ultrasound findings, treatment interventions, and outcomes, such as the duration of mechanical ventilation, ICU mortality, total ICU stay duration, and PaO2/FiO2 ratio before and after the spontaneous breathing trial (SBT).
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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.
Ming Zhong, Ph.D study chair
Fudan University
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 Retrospective, run by Shanghai Zhongshan 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?
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 26 Jul 2024. 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 Hongyu He (021-64041990 ext. 2980, he.hongyu@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LRS (time frame: through study completion，up to 28 days). 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 NCT06521515, which also lists 3 linked publications.
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 26 Jul 2024.