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临床试验/NCT06521515
NCT06521515招募中不适用

The Impact of Lung Ultrasound Morphology Patterns on Treatment Response and Weaning Outcomes in High-Risk Mechanically Ventilated Patients

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
LRS

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

LRS

时间窗: 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 (

次要结局

  • duration of mechanical ventilation(through study completion,up to 28 days)
  • ICU mortality(through study completion,up to 28 days)
  • total ICU stay duration(through study completion,up to 28 days)
  • PaO2/FiO2 ratio before and after the spontaneous breathing trial (SBT)(through study completion,up to 28 days)
  • weaning failure rates(through study completion,up to 28 days)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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