Lung Ultrasound Morphology Patterns Predict Weaning Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2025-12-30

Brief Summary

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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.

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Detailed Description

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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

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Retrospective

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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TLP group

Patients were grouped into TLP if they exhibited a tissue-like pattern in any region

Lung Ultrasound Morphology Patterns

Intervention Type DIAGNOSTIC_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.

DBP group

Patients were grouped into DBP if they displayed diffuse B-lines and shred signs in most regions.

Lung Ultrasound Morphology Patterns

Intervention Type DIAGNOSTIC_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.

Interventions

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Lung Ultrasound Morphology Patterns

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No